Speaker 1: Brought to you by Toyota. Let's go places. Welcome to
Speaker 1: Forward Thinking. Hey there, and welcome the Forward Thinking, the
Speaker 1: podcast that looks at the future and says, no pills
Speaker 1: gonna cure my ill. I got a bad case of
Speaker 1: loving you. I'm Jonathan Strickland, and I'm Joe McCormick. And Jonathan,
Speaker 1: you're back. I am back, but you might notice this
Speaker 1: is a really appropriate thing for us to cover today
Speaker 1: because my voice is dying. I've had I've been fighting
Speaker 1: off a little bit of a cold for it ever
Speaker 1: since I got back. Did you get cruise crud? Either
Speaker 1: cruise cut crud or the European boogie flu? I don't know.
Speaker 1: I mean it was. I had a great time. I
Speaker 1: sailed around the British aisles. We told the listeners many
Speaker 1: untrue stories or might not be dead. Yeah, I got
Speaker 1: a lot of concerned tweets that was dead. I don't
Speaker 1: think we said Dad was heard. It was almost definitely.
Speaker 1: Didn't tell anyone you were down. That's good. So we
Speaker 1: may have mentioned Quidditch made dismissive comments about France. I was,
Speaker 1: in fact at a castle where they did shoot some
Speaker 1: of the Quidditch scenes from Harry Potter on Castle Historic
Speaker 1: Comma The Percy's I was there for Hotspur, my wife
Speaker 1: was there for Harry Potter. Anyway, none of that has
Speaker 1: anything to do with what our topic is today, but
Speaker 1: the fact that I was talking about feeling a bit
Speaker 1: under the weather does kind of because we're talking about biosimilars,
Speaker 1: a type of drug, and you may have heard this term,
Speaker 1: and some of you may even be very familiar with it,
Speaker 1: but I to to just be honest, I had heard
Speaker 1: the term, but didn't really understand it until we started
Speaker 1: doing research for this episode. I think I think I
Speaker 1: knew nothing about it. Yeah, I think that I completely
Speaker 1: misunderstood it. We were talking right before we started up
Speaker 1: about how it was sort of a difficult topic to
Speaker 1: to wrap our heads around, partially because some of the
Speaker 1: parding about it is a little bit confused itself. Yeah,
Speaker 1: it's not misleading, at least not clear right or just
Speaker 1: not going into depth. I think I didn't really understand
Speaker 1: before the difference between biosimilar drugs and generic drugs, right
Speaker 1: and and and biosimilar drugs been in the in the
Speaker 1: press a little bit lately because of some stuff floating
Speaker 1: around the f d A hopefully not literally that that
Speaker 1: that has to do with with the way that these
Speaker 1: drugs are are going to be regulated in maybe the
Speaker 1: near future, uh, maybe a little while from now, but
Speaker 1: but yeah, So, so there is a distinct difference between
Speaker 1: biosimilar drugs and generic drugs. And let's let's let's figure
Speaker 1: that out. Let's lay down these these ground definitions, right,
Speaker 1: So first, let's just start with just the basic idea
Speaker 1: of what is a drug. Let's manufacture some drugs. Wow
Speaker 1: this episode with Downhill in a hurry. All right, So
Speaker 1: the drug is, at its most basic level, some sort
Speaker 1: of molecule that has a pharmacle logical effect on something organic.
Speaker 1: And we are going to talk about drugs for humans
Speaker 1: because that's what we are. I mean, I don't want
Speaker 1: to speak for all of us. I'm not I am
Speaker 1: definitely not almost sure. I'm definitely not a reptilian. I'm
Speaker 1: not going to not say that I'm a reptilian. Okay,
Speaker 1: I'm mostly interested in drugs for wizards. Can we talk
Speaker 1: about those. We'll get back to quidditch later. So typically
Speaker 1: when we talk about drugs, we're talking about ones that
Speaker 1: were designed through chemistry in a lab. That's the majority
Speaker 1: of the drugs we use today are of that category.
Speaker 1: Not all of them are. Some of them are biologic
Speaker 1: as opposed to, uh the the chemical approach, but we'll
Speaker 1: get into that. So when a pharmaceutical company develops a drug,
Speaker 1: it's really trying to build a molecule meant to have
Speaker 1: a particular effect on the person taking the drug, whether
Speaker 1: it's to fight a particular illness or alleviate symptoms or
Speaker 1: something along those lines. It's it's it's meant to make
Speaker 1: some kind of chemical change in your body in order
Speaker 1: to do a stuff right. Right, And typically the active
Speaker 1: ingredient is the drug itself, but an active ingredient is
Speaker 1: not the only ingredient in most drugs. You tend to
Speaker 1: have a lot of other stuff that is there. Maybe
Speaker 1: it's to act as almost like a catalyst. Sometimes it's
Speaker 1: just a filler to a carrier system to get the
Speaker 1: stuff into your stuff. Sure, yeah, so you we in
Speaker 1: the getting over into the generic drug area. UM, you
Speaker 1: would first call one of those drugs like the main
Speaker 1: one that has already been developed by a company. It's
Speaker 1: been uh filed with intellectual property, so it has its
Speaker 1: own proper name that does not necessarily relate to any
Speaker 1: of the chemicals inside that drug. It's usually a pun
Speaker 1: of some kind. Yeah, yeah, you get some or you'll
Speaker 1: just get like it will sound vaguely scientific, but then
Speaker 1: you realize that that's just a brand name that someone
Speaker 1: came up when they said this is testing. Well, yeah,
Speaker 1: maybe it would help to have an example to continue
Speaker 1: through this. Let's do aspirant. I was gonna make one up. Okay,
Speaker 1: go go ahead, make one up. Well, let's say you
Speaker 1: invent a small molecule drug that causes rapid balding for
Speaker 1: people who don't like to have haircuts. You know, they
Speaker 1: just don't want to deal with it. Advanced rapid balding.
Speaker 1: And I feel like I'm being attacked in this episode
Speaker 1: talking about I feel like I'm I've been advanced rapid
Speaker 1: balding for years. So this drug, the brand name version
Speaker 1: of it that is patented by the original drug innovator,
Speaker 1: is called Scalp Extra. Scalp Extra, that's that's the that's
Speaker 1: the brand name, brand name. Yeah, so there's an active
Speaker 1: ingredient in scalprexa. Uh what Scalp extra. Sorry, Um, well
Speaker 1: I don't need it, obviously, I've already it's it's worked
Speaker 1: on me. So Scalp Extra is the brand name. What
Speaker 1: is the active ingredient? Makes something else up? Uh, it's sugar.
Speaker 1: I don't know what it is. It's a chemical, I
Speaker 1: don't I know, But you can just make up a
Speaker 1: name for a chemical. Two for the purposes of this,
Speaker 1: It's called cubal hydride. Alright. Cubal hydride is the active
Speaker 1: ingredient in scalp extra. Alright, cubal hydride. So, uh so
Speaker 1: in the in the terms of generic drugs, you would
Speaker 1: have scalpexor, which is your reference drug, all right, and
Speaker 1: then cubal high what was it? Cub hyd cuble hydride
Speaker 1: is your is your actual active ingredient that becomes the
Speaker 1: generic term for that drug, all right. So generics are
Speaker 1: are drugs that have the same active ingredient as a
Speaker 1: brand name, and they are meant to have the same
Speaker 1: pharmacological effect as the reference drug that brand name drug
Speaker 1: Scalp Extra in this in this example that we have created.
Speaker 1: So if they're the same thing, in what sense is
Speaker 1: the generic different? Well, it has basically just to do
Speaker 1: with intellectual property law, right pretty much. Yeah. Yeah, So
Speaker 1: after the patent lifetime of the original patent on that
Speaker 1: drug expires for the drug innovator, then another company can
Speaker 1: come along and say, well, I want to make this
Speaker 1: same drug, but basically the only thing they can't do
Speaker 1: is call it by the same name. So and and
Speaker 1: frequently the some of the non active ingredients will be different, right,
Speaker 1: which also partially explains why if you've ever noticed that
Speaker 1: sometimes generic drugs don't work exactly the way that that
Speaker 1: that a brand name drug does. It could be a
Speaker 1: placebo effect, or it could be a genuine chemical difference
Speaker 1: in the way that the drug is entering your system.
Speaker 1: Right there. There can be cosmetic differences to it can
Speaker 1: be shaped, your color different, well, it might be a
Speaker 1: pill versus like the gelatine capsule type stuff. It all depends, right. So,
Speaker 1: the in the United States, the Food and Drug Administration
Speaker 1: has very specific rules for generic drugs and says that
Speaker 1: generic drug must be identical or within a range of
Speaker 1: bioequivalence to the reference drug. So it has to be
Speaker 1: that way. Now, biosimilar drugs are different from this. They
Speaker 1: are not meant to be chemically identical to a reference drug.
Speaker 1: You still do have a reference drug, so they're intended
Speaker 1: to produce medicinal effects that they are. One, they're not
Speaker 1: created through chemical synthesis, and the molecular structure is much
Speaker 1: larger and more complex than traditional brand name drugs or generics.
Speaker 1: So you first start off with a biologic therapy of
Speaker 1: some sorts. So this is this is similar in a
Speaker 1: way to the reference drug we talked about a second ago,
Speaker 1: the brand name drug, but in this case it's biologically
Speaker 1: derived UM and biosimilar is meant to replicate the effects
Speaker 1: of the reference drug, the biologic therapy, but it doesn't
Speaker 1: have to at all molecular lee resemble that reference drug,
Speaker 1: right because Okay, So, biological therapies are products that are
Speaker 1: made from biological sources, their extractions from cells or tissues
Speaker 1: or or stuff that is made inside cells and tissues. Uh.
Speaker 1: They can also be called biopharmaceuticals or biologics, and they
Speaker 1: include things like like like hormone therapies, vaccines, blood components,
Speaker 1: gene therapies, anti venom or antitoxin, insulin, stuff like that, Right,
Speaker 1: And so keep in mind we're we're talking about both
Speaker 1: generics and biosimilars are supposed to achieve the same results
Speaker 1: as their references. But in the case of generic drugs.
Speaker 1: When you break it down chemically, it is for all
Speaker 1: intents and purposes, identical to the reference. It does the
Speaker 1: same thing because it is the same right, right, It's
Speaker 1: it's a chemical structure, um and and biologic therapies are
Speaker 1: are more complicated because of a the way they're produced
Speaker 1: and be the stuff that they're made of. Right. So
Speaker 1: if you want to have like an analogy that's not
Speaker 1: drug related, you could say that if you look at
Speaker 1: a catapult and a giant sling shot, they both can
Speaker 1: propel an object a very great distance. They do it
Speaker 1: in slightly different ways, but the end result is the
Speaker 1: same and they don't physically resemble one another, right, So
Speaker 1: you could if you could design it in such a
Speaker 1: way where some of the same elements some of the
Speaker 1: same elements, which is true with biosimilars as well. So
Speaker 1: that's why I wanted to say, like again, you've got
Speaker 1: to think of biosimilars as being an attempt to create
Speaker 1: the same effect as some other reference, but it isn't
Speaker 1: identical to the reference. Not only that, but if you
Speaker 1: have two different companies trying to make biosimilar drugs, so
Speaker 1: you've got your reference biological therapy, right, that's created by somebody.
Speaker 1: You have two other companies that want to make a
Speaker 1: biosimilar therapy using that first one as its reference. The
Speaker 1: two biosimilar therapies won't resemble one another either. They will
Speaker 1: resemble the they won't physically. Yeah, I mean, I mean
Speaker 1: because because you have to reverse engineer. Because we'll look
Speaker 1: into this in a minute. But but but the way that
Speaker 1: these things are patented, Uh, people don't or companies rather
Speaker 1: don't have to write down everything about their process. They
Speaker 1: just they just patent the end result and so um so,
Speaker 1: so when when another company comes along and tries to
Speaker 1: reverse engineer that process, then what they come up with
Speaker 1: might be wildly different. Yes, And so, as we've already
Speaker 1: alluded to, making these things is complicated. I mean, you're
Speaker 1: you're talking about like almost like growing a drug as
Speaker 1: opposed to synthesizing one through chemistry. And because of this,
Speaker 1: the whole process requires a lot of precision and expertise.
Speaker 1: It is not an easy thing to do. It's not
Speaker 1: easy to produce it on a mass scale either. So
Speaker 1: for uh, that reason, a lot of biologic therapies tend
Speaker 1: to be incredibly expensive because it's not it's not easy
Speaker 1: to do, and it's not easy to do on a
Speaker 1: big scale. So in order to balance that out, companies
Speaker 1: end up charging more for their various biologic therapies. It's
Speaker 1: not true in every single case, but in a lot
Speaker 1: of cases it is, so there was there's hope that
Speaker 1: biosimilars can help bring that cost down own. But we'll
Speaker 1: get into how that gets a little complicated and just
Speaker 1: a little further um. Now, the other issue we need
Speaker 1: to talk about is the idea of testing drugs. We've
Speaker 1: talked about drug testing and clinical trials in previous episodes.
Speaker 1: This is a pretty exhaustive process for good reason. You
Speaker 1: want to make certain that the drug that you are
Speaker 1: developing is efficacious and it is not toxic. Without this process,
Speaker 1: we would be back in the era of patent medicine, right, yes,
Speaker 1: And we'll talk about patent medicine pretty soon too. Patent
Speaker 1: medicine and patented medicines yet more confusing terminology. But that
Speaker 1: is an excellent, excellent point. I mean, we would if
Speaker 1: you go, if you think about it, without that clinical testing,
Speaker 1: you're getting down to, uh, the idea that that a
Speaker 1: company could sell a drug claiming that it has an
Speaker 1: effect without having to prove it or even make certain
Speaker 1: that it isn't it self harmful to people, and we
Speaker 1: don't want that. That's why we have organizations like in
Speaker 1: the US, the Food and Drug Administration to make sure
Speaker 1: that companies are following very specific guidelines to not cause harm.
Speaker 1: So with generic drugs, the testing is a little more
Speaker 1: simple because you've already got a reference drug that is
Speaker 1: chemically identical to the generic drug, at least for the
Speaker 1: active ingredient, So you already know what it does to people, right, Yeah,
Speaker 1: it's already it's already passed through clinical trials before it
Speaker 1: could ever go onto the market. Now that doesn't that
Speaker 1: doesn't mean generic drugs get a free pass and just
Speaker 1: immediately go straight to store shelves, but it does mean
Speaker 1: that a lot of that work has already been done,
Speaker 1: and so the clinical trials are usually smaller and less exhaustive.
Speaker 1: I would say that's probably also a reason why generic
Speaker 1: drugs are cheaper. Well, yeah, because as much to get
Speaker 1: to the stores, right, yeah, I think they can be
Speaker 1: more profitable little at a lower cost. Right, And and
Speaker 1: they're also cheaper because at that point it's a longer monopoly, right,
Speaker 1: you can't. Now, they can undercut, right, they can undercut
Speaker 1: the the the main proprietor of said drug. Well, biosimilars
Speaker 1: are totally different, right, because we've just said a biosimilar
Speaker 1: drug can be completely structured in a different way than
Speaker 1: it's reference drug. Um it's supposed to do the same
Speaker 1: thing pharmacologically, but structurally it could be very different. Because
Speaker 1: it could be very different, then there's the question of well,
Speaker 1: will this have different symptoms, will be have a different
Speaker 1: toxicity level than say, the reference drug does. It has
Speaker 1: to undergo much more extensive clinical trials than generics tend to.
Speaker 1: So that is another reason why the cost difference between
Speaker 1: a biosimilar drug and the reference drug may not be
Speaker 1: as great as you would see in generic drugs, because
Speaker 1: you still have to undergo this incredibly exhaustive testing for
Speaker 1: good reason. I'm not I'm not suggesting that that's a
Speaker 1: bad idea. Sure, yeah, yeah, but but the but the
Speaker 1: market is still in play. You'll still have the effect
Speaker 1: of um of companies attempting to undercut each other's prices. Right,
Speaker 1: The question is just how far lower can they go?
Speaker 1: Considering the fact that the UM the investment in biosimilars
Speaker 1: is generally speaking higher than it is to go into
Speaker 1: the business of designing generic drugs, or not designing but
Speaker 1: producing generic drugs. So let's let's talk about this idea
Speaker 1: of copyrights and patents because it does play directly into
Speaker 1: generics and biosimilars. It's not all science and technology, it's
Speaker 1: also economics and intellectual property. Um. So when you start
Speaker 1: looking at large scale drug manufacturing, you have to go
Speaker 1: all the way back to the Revolutionary War here in
Speaker 1: the United States. That's when uh Andrew Craiggie begin established
Speaker 1: a manufacturing facility in Pennsylvania and he became the first
Speaker 1: Apothecary General of the United States. General. We don't have
Speaker 1: one of those anymore, we know he's entitled though. Yeah
Speaker 1: we got got rid of got rid of that shortly
Speaker 1: after the Alchemist General. Um. But so by seventeen inventors
Speaker 1: were starting to file patents in the United States for
Speaker 1: medical devices and medicines. By the mid eighteen hundreds, companies
Speaker 1: began to form around new manufacturing practices, which at the
Speaker 1: time that was actually more important than the medicines themselves.
Speaker 1: The way you manufactured them became much more important than
Speaker 1: whatever it was you were making uh. And the reason
Speaker 1: for that is that in the United States we were
Speaker 1: really dependent upon other parts of the world to actually
Speaker 1: research and develop medicines. Then what would happen is those entities,
Speaker 1: mostly in Europe, would essentially license the medicines into the
Speaker 1: United States where we could produce them here, but it
Speaker 1: was because somewhere else that's where that's where they were
Speaker 1: being developed. So it was like an interesting thing to
Speaker 1: look at that that we weren't really developing drugs in
Speaker 1: the US at that time, we were simply producing them
Speaker 1: based upon the work people in Europe were doing. So
Speaker 1: that actually became a bit of a problem because well
Speaker 1: by the end of the nineteenth century, German manufacturers were
Speaker 1: holding most of the patents around major medicines in the
Speaker 1: United States UM and in fact, there were subsidiary companies
Speaker 1: in the U S subsidiaries of those German companies that
Speaker 1: were producing the drugs here in the US, and they
Speaker 1: didn't have the full recipe. Like it's like you would
Speaker 1: get a jar with you know ingredient X, and then
Speaker 1: you would you would go ahead and do the mixture
Speaker 1: as right, but you didn't know what was in ingredient X. Um,
Speaker 1: so it was kind of interesting that it was being
Speaker 1: kept as a sort of a trade secret, so even
Speaker 1: though it was being produced in the US, people in
Speaker 1: the U s didn't know what was going into it.
Speaker 1: But okay, so we're we're coming out of the eighteen
Speaker 1: hundreds going into the nineteen hundreds, and lots of these
Speaker 1: companies were from Germany. Yeah. Yeah, so you're you're you're
Speaker 1: getting your you're thinking about like what have ends around oh,
Speaker 1: nineteen fourteen too, that you know, are somewhere around that
Speaker 1: range where you know, some conflict is happening in Europe.
Speaker 1: They they're entering into a you know, the war to
Speaker 1: end all wars. Yeah, except you know, of course it
Speaker 1: didn't end all wars so much so that no one
Speaker 1: at the time called it World War One because they
Speaker 1: were all very optimistic. Um though, at any rate, world
Speaker 1: War one happens, and because it happens, it ends up
Speaker 1: creating a problem where the US is not able to
Speaker 1: access those drugs, those medicines that were coming from Germany anymore.
Speaker 1: The United States was trying to find ways to make
Speaker 1: certain that it wasn't providing financial support to Germany during
Speaker 1: World War One. Sure, I'm sure that also some trade
Speaker 1: routes were a little bit disrupted by by the little
Speaker 1: bit seating. Yeah, so there was actually a lot past
Speaker 1: that that basically let Americans get around this, this entire thing. Yeah. Yeah,
Speaker 1: you get to a point where you're like, well, how
Speaker 1: do we how do we deliver upon medicines? How do
Speaker 1: we do this in this time of tribulation? What what
Speaker 1: are our options? The United States government in nineteen seventeen
Speaker 1: passes the Trading with the Enemy Act and then actually
Speaker 1: allowed companies to produce products that were otherwise protected by
Speaker 1: patents if those patents were held by individuals or companies
Speaker 1: and enemy states. Its invenient. So right, like, your intellectual
Speaker 1: property doesn't count if you are at war with the
Speaker 1: United States and such a fascinating precedent. I love that. Yeah,
Speaker 1: it's It's also the way I live my life. When
Speaker 1: I get into a spat with somebody, I'm just like, well,
Speaker 1: their ideas are no longer relevance, and I can I
Speaker 1: can take whatever they had. Well, now, so does this
Speaker 1: also mean that if somebody like physically assaults you, you
Speaker 1: can plagiarize their novel? I mean, that's how princip If
Speaker 1: that's accurate then I'm gonna I'm gonna go to go
Speaker 1: out to the writer events and like just start picking
Speaker 1: fights with people. So like, oh man, what are you
Speaker 1: gonna do? Punch me, I'm gonna steal your short story.
Speaker 1: I think you're gonna need to be a little more
Speaker 1: specific with your wording because technically you can do that.
Speaker 1: You just can't get away. Uh. Yeah, you can't get
Speaker 1: away with it. But you you you could physically do
Speaker 1: that thing. Um. So we get through World War One, uh,
Speaker 1: and then we started getting into a new thought process
Speaker 1: in the United States. And this is what allows generic
Speaker 1: drugs to really become a thing. Back in the nineteen twenties.
Speaker 1: It's a little company called Bayer, going back to aspirin. Uh.
Speaker 1: They were writing high on the headaches of the world,
Speaker 1: selling aspirate to whomever was ailing. But then you've got
Speaker 1: a lot of companies that were producing copycats. They essentially,
Speaker 1: you know, we're creating their own and we're making their own. Yeah,
Speaker 1: they're just making their own. Uh. Aspirin essentially or asked
Speaker 1: generic aspirin um and Bayer ended up going into litigious
Speaker 1: actions suing lots of different companies and individuals. The courts
Speaker 1: in the United States, however, decide the Bayar couldn't demand
Speaker 1: stores to remove generic versions of aspirant to prevent them
Speaker 1: from being made or prevent them from being made. Rather,
Speaker 1: so then you get to the Second World War, and
Speaker 1: that also reinforced this idea that the United States really
Speaker 1: needed to invest in research and development of its own
Speaker 1: as far as medicines are concerned. It could no longer
Speaker 1: depend upon outside sources to develop this medication. So they
Speaker 1: started to really, uh we see see a kind of
Speaker 1: a a boom in the pharmacological industry here in the
Speaker 1: US post World War two. Yeah, yeah, we all realized
Speaker 1: it was it's it's a national resource. It's it's important
Speaker 1: to be able to be able to fix our our populace.
Speaker 1: It's it's it was. It was essentially a type of
Speaker 1: national security, right, just like just like we talked about
Speaker 1: fuel in terms of national security today, medicine certainly fell
Speaker 1: into that same category. Um. And you often will hear
Speaker 1: arguments similar to the US today about companies that develop
Speaker 1: a drug and of course they will protect that drug,
Speaker 1: and for the duration of that protection they can charge
Speaker 1: pretty much whatever they like, and there's not really any
Speaker 1: alternative to it. And you talk about things like, well
Speaker 1: that that seems really predatory. Well, during post World War
Speaker 1: two era, we were attempting to avoid a global version
Speaker 1: of that. We still have the corporate version of that.
Speaker 1: So then you get into the idea of patents. Uh,
Speaker 1: now this we brought this up earlier, Joe. You mentioned
Speaker 1: patent medicine. Patent medicine ironically counterintuitive name, Yeah, ironically it
Speaker 1: doesn't have a patent. A patent medicine is usually what
Speaker 1: we call. You know, you had a snake oil sales
Speaker 1: and running around with a cart full of bottles of
Speaker 1: something called like you know, Uncle Uncle Jimmy's Cure Everything juice,
Speaker 1: And I always think of a rheumatism, diarrhea and cancer. Yeah,
Speaker 1: fix it all and who turns out? What's in it
Speaker 1: is usually like alcohol and some turpentine or something. It
Speaker 1: always it always makes me think of a Doc Terminus
Speaker 1: from the movie Pete's Dragon, Uh, played by Jim Dale,
Speaker 1: an amazing Disney villain anyway, so he's not in the
Speaker 1: new one. I digress. I was on a Disney cruise,
Speaker 1: so my mind is also still with Disney. Um. So, yeah,
Speaker 1: patent medicine was not patented and The reason it wasn't
Speaker 1: patented is that when you file for a patent, you
Speaker 1: have to explain what your invention is and how it
Speaker 1: works in general, and the idea being that if you've
Speaker 1: come up with an idea, and you that idea has
Speaker 1: the potential to benefit mankind as a whole, then by
Speaker 1: filing for the patent one you've protected your idea. You
Speaker 1: you are supposed to be granted exclusive rights to that
Speaker 1: idea for a certain length of time, however long the
Speaker 1: patent is good for. Once that time expires, anyone can
Speaker 1: use the patent you have filed as the basis for
Speaker 1: their own work, and they can make their own version
Speaker 1: of the thing you have invented. Yeah. So, so what
Speaker 1: you get into with with stuff like patent medicines is
Speaker 1: the idea that that you don't want anyone else to
Speaker 1: ever make the stuff that you just made, or at
Speaker 1: least or you don't want to have to prove that
Speaker 1: it works and that too. Yeah, yeah, one of the two, certainly,
Speaker 1: you know. For for example, I believe that the w
Speaker 1: D forty is still not patented because the makers of
Speaker 1: it just don't want anyone It's like a trade. Yeah.
Speaker 1: So people who purveyors of patent medicine would claim that
Speaker 1: their medicines are trade secrets to they don't want the
Speaker 1: secret out because they are the ones who produce this
Speaker 1: miracle cure and uh and and they're doing so responsibly
Speaker 1: and you should buy from them. Meanwhile, patented medicines have
Speaker 1: actually gone through this process of being filed with a
Speaker 1: patent office and being issued a patent. So patent medicine
Speaker 1: versus patented medicine, they're opposite of each other, which is
Speaker 1: hard to get your mind around when you first start
Speaker 1: reading about these sort of things. Also tells us that
Speaker 1: patent medicine it's a historical term. Yeah, yeah, yeah, although
Speaker 1: actually I wonder if some of the alternative medicines out there,
Speaker 1: um kind of fall into that same category. Yeah, I
Speaker 1: would imagine so well, and a lot of those alternative medicines.
Speaker 1: You know, people say, well, this is not a drug.
Speaker 1: It has a chemical component in it that has a
Speaker 1: pharmacological effect. By definition, it's a drug. It's just an
Speaker 1: unregulated drug that you cannot guarantee that you will have
Speaker 1: the same amount of active ingredient from one dose to
Speaker 1: the next. I'd say most not legally speaking, but Yeah,
Speaker 1: most alternative medicines today probably don't have turpentine in them,
Speaker 1: so they're less likely to make you violently sick. I do,
Speaker 1: Like you said, most and probably, but they might not
Speaker 1: be any more effect at any rate. You know this,
Speaker 1: This whole discussion of patent versus patented illustrates that language
Speaker 1: is dumb. Uh. Also, we can we should mention that
Speaker 1: drugs are not just necessarily protected by patents. Patents do
Speaker 1: expire after a given term like seven to twelve years,
Speaker 1: depending upon the place and the type of patent you're
Speaker 1: talking about. Um, and sometimes some patents again, depending on
Speaker 1: where you are, could last longer than that. Uh. Drugs
Speaker 1: can also be protected by trademarks. Now, trademarks are not
Speaker 1: protecting the composition of the drug. It's really protecting the brand,
Speaker 1: the name, right, the name and perhaps the way that
Speaker 1: the bottle looks, stuff like that, Yes, exactly, or even
Speaker 1: the design of the pill. Yeah exactly. So So if
Speaker 1: if what was our what was our fancy drug scalp SCALP,
Speaker 1: now that's the that's the patented version, well that would
Speaker 1: be they would also be the trademarked version. Yeah. Yeah, yeah,
Speaker 1: you can't call just any old q hi hyd Uh
Speaker 1: scalp extra right, you have to come up with another
Speaker 1: scalp pun and you couldn't. You couldn't market it in
Speaker 1: a bottle that looked similar to a scalpex or bottle
Speaker 1: because most likely that would also be trademarks are too
Speaker 1: similar to similar, and trademark is one of those things
Speaker 1: that you have to defend in order to keep it.
Speaker 1: If you trademark something and you don't defend that trademark,
Speaker 1: then uh you can you won't have a whole lot
Speaker 1: of ground to stand on if you ultimately decide, hey,
Speaker 1: I've had enough of this, I'm going to go out
Speaker 1: there and go after these guys. Yeah, I've heard that
Speaker 1: that's a common explanation for like, oh, why is some
Speaker 1: company being a jerk going after some small fish? You
Speaker 1: did some you know, little tiny trademark infringement. Uh, And
Speaker 1: I think it's sort of about legal precedent. They're afraid
Speaker 1: if some rival company seems that they haven't pursued trademark
Speaker 1: infringement rights against the small fish, then they have the
Speaker 1: precedent to take advantage of it at a large scale exactly.
Speaker 1: So Uh. Again, once that exclusivity of the the patent
Speaker 1: expires and other companies are allowed to get into the
Speaker 1: game and use that same idea to make their own product.
Speaker 1: That's where you see generic drugs come in. In the
Speaker 1: chemical side of things, like the small molecule type of drugs. Uh,
Speaker 1: that's when generics can hit the market. It's also when
Speaker 1: biosimilars can hit the market. But the big difference here
Speaker 1: is that when you're talking about a biosimilar drug. Uh,
Speaker 1: the people who make or the companies that make biologic
Speaker 1: therapies don't have to reveal everything that goes into making
Speaker 1: that therapy. And you mentioned this earlier, Yeah, because because
Speaker 1: when you write when when when you patent to this
Speaker 1: kind of thing, you're not necessarily patenting the process. You're
Speaker 1: patenting the resulting product. Um, you can separately patent to
Speaker 1: the process. Maybe sometimes depending on what machinery you've created
Speaker 1: or stuff like that. But uh, but in general, since
Speaker 1: you're working with with living tissue and living systems and
Speaker 1: and stuff that is unpatentable like DNA, it falls into
Speaker 1: that trade secret category. Right. So then that means if
Speaker 1: you want to create a biosimilar, then what you have
Speaker 1: to do is kind of work backward. You might know
Speaker 1: in general what goes into the biologic therapy, but in
Speaker 1: order to get to that destination, you may have to
Speaker 1: plot your own course, and thus you have to go
Speaker 1: through that big clinical testing because the the approach you
Speaker 1: take might be dramatically different from the approach the the
Speaker 1: producer of the reference drug took. So let's talk a
Speaker 1: little bit about the history of biosimilars. This was interesting
Speaker 1: to me too, because it went back further than I
Speaker 1: had imagined when you start talking about biological therapies. So
Speaker 1: in the US, the government got involved with biologically derived
Speaker 1: products way back in nineteen o two with the Biologics
Speaker 1: Control Act nineteen o two. UH. And it actually was
Speaker 1: this This shouldn't really be much of a surprise. It
Speaker 1: was that response to a tragedy that had happened in
Speaker 1: nineteen o one. There was a diph theory any toxin
Speaker 1: serum that was derived from the blood of horses, and unfortunately,
Speaker 1: one batch of that antitoxin serum caused the deaths of
Speaker 1: thirteen children. When there was an investigation to find out
Speaker 1: what caused this, UH, it went back to a St.
Speaker 1: Louis manufacturing company that had used the blood of a
Speaker 1: horse that had been infected with tetanus. So the Act
Speaker 1: was created specifically to put protections in place to prevent
Speaker 1: that sort of thing from happening again in the future. Now,
Speaker 1: with a lot of these biologic therapies, a lot of
Speaker 1: them are are relatively young. I mean, they don't all
Speaker 1: date back to nineteen o two, right, so some of
Speaker 1: them are just getting to the age where those patents
Speaker 1: that were filed back when they were first developed are
Speaker 1: expiring soon. That is another reason why this discussion of
Speaker 1: biosimilars has kind of popped up in the media, because
Speaker 1: we're now getting to a point where that protects and expires,
Speaker 1: and other companies can actually legally create their biosimilars to
Speaker 1: the biologic therapy, and recently it's happened with a couple
Speaker 1: of drugs I believe for for rheumatism, for for rheumatoid I.
Speaker 1: Threat is right, and this is still so new that
Speaker 1: we don't have a really well thought out policy that
Speaker 1: that is specifically intended to regulate this sort of stuff.
Speaker 1: In the United States, biosimilars currently fall under the regulation
Speaker 1: of the FDA's Public Health Service Act, but there are
Speaker 1: motions to create a formalized approach to the testing and
Speaker 1: approval to biosimilars. So right now, the way if the
Speaker 1: FDA treats this, it makes sense if you were listening
Speaker 1: earlier to the podcast, they treat it like every biosimilar
Speaker 1: is actually an entirely new biologic therapy, right so it's
Speaker 1: just the same as if you had come up with
Speaker 1: a brand new process to treat a specific illness or
Speaker 1: set of symptoms. And so a lot of people are thinking, well,
Speaker 1: there's got to be a better way of doing this,
Speaker 1: and that in turn will one encourage more companies to
Speaker 1: develop biosimilars and to help bring that cost of the
Speaker 1: final therapies down, because if you're able to streamline this approach, uh,
Speaker 1: the investment on the end of the companies won't be
Speaker 1: as great SUH. And I did want to also put
Speaker 1: in that not all biologic therapies fall under the regulations
Speaker 1: for for for this biosimilar drug kind of thing, like
Speaker 1: a like if if you if if you've ever taken
Speaker 1: insulin or birth control pills, then you know that those
Speaker 1: are regulated the same way that the chemical drugs are
Speaker 1: here here in the United States at any rate, and
Speaker 1: so so generics of those can be made and called
Speaker 1: generics even though they're technically a biologic therapy. Uh and
Speaker 1: it's for a number of honestly exhausting legal reasons that
Speaker 1: those have been categorized that way. But yeah, So glancing
Speaker 1: again in the future, it looks like biosimilars are going
Speaker 1: to play an increasingly important role in medicine. It may, however,
Speaker 1: not lead to some sort of glorious renaissance of cheap therapies. Right,
Speaker 1: we may see less expensive therapies. In fact, if we
Speaker 1: don't see less expensive therapies, they're gonna be some companies
Speaker 1: that are out of some serious money. Because the only
Speaker 1: reason to get into the game is if you can
Speaker 1: produce a a therapy that is effective for the treatment
Speaker 1: of a particular condition or illness or whatever at a
Speaker 1: lower selling cost than the the leading brand of that therapy.
Speaker 1: Otherwise you're not you're not gonna sell anything. You're not
Speaker 1: gonna you don't have a you don't have something to
Speaker 1: entice people to buy your approach versus the name brand approach.
Speaker 1: So they will be cheaper. The question is will they
Speaker 1: be significantly cheaper, And they may not be. There are
Speaker 1: some people who are skeptical that it will be a
Speaker 1: significant drop in price. So then we also have other
Speaker 1: complications such as how are they going to be affected
Speaker 1: through things like insurance, Like how how is insurance going
Speaker 1: to um cover a biosimilar versus the reference biologic therapy?
Speaker 1: And we don't have the answers to this yet. These
Speaker 1: are still questions that have to be solved. And keep
Speaker 1: in mind that we're talking about a realm of science
Speaker 1: that is still relatively young and is outpacing legal and
Speaker 1: insurance realms. So it's gonna be messy for a while
Speaker 1: and it may not shake out for several years until
Speaker 1: we've reached a point where we have a better understanding
Speaker 1: on from all perspectives. Yeah. Yeah, if you're asking about
Speaker 1: the direct future of biosimilar as, I would say that
Speaker 1: it's something of a regulation headache at the current moment.
Speaker 1: I mean, you know, partially for for the reasons of
Speaker 1: protecting um these companies interests, but also for the reasons
Speaker 1: of protecting doctors and patients as they come to understand
Speaker 1: how the products work and comprehend the potential risks and
Speaker 1: using them versus a previous therapy that they have used. Right, So, ultimately,
Speaker 1: I think what we're going to see is that these
Speaker 1: therapies and similar therapies, these biologic therapies, whether it's the
Speaker 1: reference one or the the various bios similars out there,
Speaker 1: they're going to become more accessible and at least in theory,
Speaker 1: they will become less expensive. Both of those are good things. Uh,
Speaker 1: It's just one of those deals where we really felt
Speaker 1: that a lot of that coverage out there was treating
Speaker 1: this so so much on a surface level that it's
Speaker 1: hard to understand why it's complicated until you start really
Speaker 1: diving into it, you realize, Oh, it's complicated because one
Speaker 1: you're talking about biology, which is not necessarily simple. I mean, uh,
Speaker 1: you know, every time you work with a cell, you're
Speaker 1: not guaranteed have specifically the identical experience like you would
Speaker 1: with using the exact same chemicals in a pristine laboratory setting. Yeah. Sure.
Speaker 1: And although the ingredients in in many biosimilar drugs, the proteins,
Speaker 1: the sugars, the DNA bits, any of that stuff is
Speaker 1: hypothetically a chemical and hypothetically can be reproduced consistently, you
Speaker 1: don't again, because you throw in that that you're doing
Speaker 1: stuff with living stuff factor. Yeah, living stuff can have
Speaker 1: slight differentiation from from instance to instant. Yes, so that
Speaker 1: ends up being a bit of a complication. But then
Speaker 1: on top of that, you've got the complication of that
Speaker 1: where people and we have to figure out how to
Speaker 1: handle this new, relatively new discipline and uh. And so
Speaker 1: that's why it's so complicated, partially because we made it
Speaker 1: that way. But this was really interesting to look into.
Speaker 1: I really learned a lot as I started to research
Speaker 1: this stuff that you know, I thought I knew, and
Speaker 1: then as I was reading, I'm like, wow, I had
Speaker 1: a complete Uh, I had the wrong perspective on this.
Speaker 1: You know, this topic makes me think that in the future,
Speaker 1: we should maybe do an episode entirely devoted to the
Speaker 1: future of medical research incentives, because the whole the thinking
Speaker 1: behind the patent system, as you said earlier, you know,
Speaker 1: part of it is about in the long term, sharing information,
Speaker 1: but it's also about providing incentive for research. Right is
Speaker 1: saying that it's sort of giving you a guarantee that
Speaker 1: if you forge a path that is a productive path,
Speaker 1: you will reap rewards from it, and other people can't
Speaker 1: scoop your rewards away. Um, And so I wonder, I
Speaker 1: wonder if they're interesting trains of thought about what types
Speaker 1: of incentives for research will continue into the future. I mean,
Speaker 1: will you always have to have the same kind of
Speaker 1: promise from the market to make people invest the time
Speaker 1: and money into life saving research. Well, and we could
Speaker 1: also have an interesting discussion about Salk and the polio vaccine,
Speaker 1: because there's the the infamous exchange where he developed the
Speaker 1: polio vaccine and he was asked who holds the patent
Speaker 1: on it? And he says, well, I I suppose the
Speaker 1: people hold the patent on it. I mean, would you
Speaker 1: patent the sun? And so there are people who champion
Speaker 1: him as saying that this was a person who developed
Speaker 1: a uh an approach to stave off a devastating disease
Speaker 1: for the good of all humans, right, like an altruistic act,
Speaker 1: And the truth of the matter gets a little more
Speaker 1: muddy and complicated. But that would be a great side
Speaker 1: discussion for that particular episode, I would say, so keep
Speaker 1: an ear out for that in the future. Meanwhile, make
Speaker 1: sure that you go and check out the videos we've
Speaker 1: been doing for Forward Thinking this season. I think that
Speaker 1: there's some of the strong ones we've produced so far.
Speaker 1: And uh if you have any suggestions for future episodes,
Speaker 1: or you have a question about something we've talked about
Speaker 1: in the past, send it our way. The email addresses
Speaker 1: f W Thinking at how Stuff Works dot com, or
Speaker 1: you can drop us the line on Twitter where FW
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