Biosimilar Drugs

since I got back. Did you get cruise crud? Either cruise cut crud or the European boogie flu? I don't know. I mean it was. I had a great time. I sailed around the British aisles. We told the listeners many untrue stories or might not be dead. Yeah, I got a lot of concerned tweets that was dead. I don't think we said Dad was heard. It was almost definitely. Didn't tell anyone you were down. That's good. So we

may have mentioned Quidditch made dismissive comments about France. I was, in fact at a castle where they did shoot some of the Quidditch scenes from Harry Potter on Castle Historic Comma The Percy's I was there for Hotspur, my wife

was there for Harry Potter. Anyway, none of that has anything to do with what our topic is today, but the fact that I was talking about feeling a bit under the weather does kind of because we're talking about biosimilars, a type of drug, and you may have heard this term, and some of you may even be very familiar with it, but I to to just be honest, I had heard the term, but didn't really understand it until we started doing research for this episode. I think I think I

knew nothing about it. Yeah, I think that I completely misunderstood it. We were talking right before we started up about how it was sort of a difficult topic to to wrap our heads around, partially because some of the parding about it is a little bit confused itself. Yeah, it's not misleading, at least not clear right or just

not going into depth. I think I didn't really understand before the difference between biosimilar drugs and generic drugs, right and and and biosimilar drugs been in the in the press a little bit lately because of some stuff floating around the f d A hopefully not literally that that that has to do with with the way that these drugs are are going to be regulated in maybe the near future, uh, maybe a little while from now, but but yeah, So, so there is a distinct difference between

biosimilar drugs and generic drugs. And let's let's let's figure that out. Let's lay down these these ground definitions, right, So first, let's just start with just the basic idea of what is a drug. Let's manufacture some drugs. Wow this episode with Downhill in a hurry. All right, So the drug is, at its most basic level, some sort of molecule that has a pharmacle logical effect on something organic. And we are going to talk about drugs for humans

because that's what we are. I mean, I don't want to speak for all of us. I'm not I am definitely not almost sure. I'm definitely not a reptilian. I'm not going to not say that I'm a reptilian. Okay, I'm mostly interested in drugs for wizards. Can we talk about those. We'll get back to quidditch later. So typically when we talk about drugs, we're talking about ones that were designed through chemistry in a lab. That's the majority of the drugs we use today are of that category.

Not all of them are. Some of them are biologic as opposed to, uh the the chemical approach, but we'll get into that. So when a pharmaceutical company develops a drug, it's really trying to build a molecule meant to have a particular effect on the person taking the drug, whether it's to fight a particular illness or alleviate symptoms or something along those lines. It's it's it's meant to make some kind of chemical change in your body in order

to do a stuff right. Right, And typically the active ingredient is the drug itself, but an active ingredient is not the only ingredient in most drugs. You tend to have a lot of other stuff that is there. Maybe it's to act as almost like a catalyst. Sometimes it's just a filler to a carrier system to get the stuff into your stuff. Sure, yeah, so you we in the getting over into the generic drug area. UM, you would first call one of those drugs like the main

one that has already been developed by a company. It's been uh filed with intellectual property, so it has its own proper name that does not necessarily relate to any of the chemicals inside that drug. It's usually a pun of some kind. Yeah, yeah, you get some or you'll just get like it will sound vaguely scientific, but then you realize that that's just a brand name that someone came up when they said this is testing. Well, yeah, maybe it would help to have an example to continue

through this. Let's do aspirant. I was gonna make one up. Okay, go go ahead, make one up. Well, let's say you invent a small molecule drug that causes rapid balding for people who don't like to have haircuts. You know, they just don't want to deal with it. Advanced rapid balding. And I feel like I'm being attacked in this episode talking about I feel like I'm I've been advanced rapid balding for years. So this drug, the brand name version of it that is patented by the original drug innovator,

is called Scalp Extra. Scalp Extra, that's that's the that's the brand name, brand name. Yeah, so there's an active ingredient in scalprexa. Uh what Scalp extra. Sorry, Um, well I don't need it, obviously, I've already it's it's worked on me. So Scalp Extra is the brand name. What is the active ingredient? Makes something else up? Uh, it's sugar. I don't know what it is. It's a chemical, I don't I know, But you can just make up a name for a chemical. Two for the purposes of this,

It's called cubal hydride. Alright. Cubal hydride is the active ingredient in scalp extra. Alright, cubal hydride. So, uh so in the in the terms of generic drugs, you would have scalpexor, which is your reference drug, all right, and then cubal high what was it? Cub hyd cuble hydride is your is your actual active ingredient that becomes the

generic term for that drug, all right. So generics are are drugs that have the same active ingredient as a brand name, and they are meant to have the same pharmacological effect as the reference drug that brand name drug Scalp Extra in this in this example that we have created. So if they're the same thing, in what sense is the generic different? Well, it has basically just to do

with intellectual property law, right pretty much. Yeah. Yeah, So after the patent lifetime of the original patent on that drug expires for the drug innovator, then another company can come along and say, well, I want to make this same drug, but basically the only thing they can't do

is call it by the same name. So and and frequently the some of the non active ingredients will be different, right, which also partially explains why if you've ever noticed that sometimes generic drugs don't work exactly the way that that that a brand name drug does. It could be a placebo effect, or it could be a genuine chemical difference in the way that the drug is entering your system.

Right there. There can be cosmetic differences to it can be shaped, your color different, well, it might be a pill versus like the gelatine capsule type stuff. It all depends, right. So, the in the United States, the Food and Drug Administration has very specific rules for generic drugs and says that generic drug must be identical or within a range of bioequivalence to the reference drug. So it has to be

that way. Now, biosimilar drugs are different from this. They are not meant to be chemically identical to a reference drug. You still do have a reference drug, so they're intended to produce medicinal effects that they are. One, they're not created through chemical synthesis, and the molecular structure is much larger and more complex than traditional brand name drugs or generics. So you first start off with a biologic therapy of

some sorts. So this is this is similar in a way to the reference drug we talked about a second ago, the brand name drug, but in this case it's biologically derived UM and biosimilar is meant to replicate the effects of the reference drug, the biologic therapy, but it doesn't have to at all molecular lee resemble that reference drug, right because Okay, So, biological therapies are products that are made from biological sources, their extractions from cells or tissues

or or stuff that is made inside cells and tissues. Uh. They can also be called biopharmaceuticals or biologics, and they include things like like like hormone therapies, vaccines, blood components, gene therapies, anti venom or antitoxin, insulin, stuff like that, Right, And so keep in mind we're we're talking about both generics and biosimilars are supposed to achieve the same results as their references. But in the case of generic drugs. When you break it down chemically, it is for all

intents and purposes, identical to the reference. It does the same thing because it is the same right, right, It's it's a chemical structure, um and and biologic therapies are are more complicated because of a the way they're produced and be the stuff that they're made of. Right. So if you want to have like an analogy that's not drug related, you could say that if you look at a catapult and a giant sling shot, they both can

propel an object a very great distance. They do it in slightly different ways, but the end result is the same and they don't physically resemble one another, right, So you could if you could design it in such a way where some of the same elements some of the same elements, which is true with biosimilars as well. So that's why I wanted to say, like again, you've got to think of biosimilars as being an attempt to create the same effect as some other reference, but it isn't

identical to the reference. Not only that, but if you have two different companies trying to make biosimilar drugs, so you've got your reference biological therapy, right, that's created by somebody. You have two other companies that want to make a biosimilar therapy using that first one as its reference. The two biosimilar therapies won't resemble one another either. They will resemble the they won't physically. Yeah, I mean, I mean

because because you have to reverse engineer. Because we'll look into this in a minute. But but but the way that these things are patented, Uh, people don't or companies rather don't have to write down everything about their process. They just they just patent the end result and so um so, so when when another company comes along and tries to reverse engineer that process, then what they come up with might be wildly different. Yes, And so, as we've already

alluded to, making these things is complicated. I mean, you're you're talking about like almost like growing a drug as opposed to synthesizing one through chemistry. And because of this, the whole process requires a lot of precision and expertise. It is not an easy thing to do. It's not easy to produce it on a mass scale either. So for uh, that reason, a lot of biologic therapies tend to be incredibly expensive because it's not it's not easy to do, and it's not easy to do on a

big scale. So in order to balance that out, companies end up charging more for their various biologic therapies. It's not true in every single case, but in a lot of cases it is, so there was there's hope that biosimilars can help bring that cost down own. But we'll get into how that gets a little complicated and just a little further um. Now, the other issue we need to talk about is the idea of testing drugs. We've talked about drug testing and clinical trials in previous episodes.

This is a pretty exhaustive process for good reason. You want to make certain that the drug that you are developing is efficacious and it is not toxic. Without this process, we would be back in the era of patent medicine, right, yes, And we'll talk about patent medicine pretty soon too. Patent medicine and patented medicines yet more confusing terminology. But that

is an excellent, excellent point. I mean, we would if you go, if you think about it, without that clinical testing, you're getting down to, uh, the idea that that a company could sell a drug claiming that it has an effect without having to prove it or even make certain that it isn't it self harmful to people, and we

don't want that. That's why we have organizations like in the US, the Food and Drug Administration to make sure that companies are following very specific guidelines to not cause harm. So with generic drugs, the testing is a little more simple because you've already got a reference drug that is chemically identical to the generic drug, at least for the active ingredient, So you already know what it does to people, right, Yeah, it's already it's already passed through clinical trials before it

could ever go onto the market. Now that doesn't that doesn't mean generic drugs get a free pass and just immediately go straight to store shelves, but it does mean that a lot of that work has already been done, and so the clinical trials are usually smaller and less exhaustive. I would say that's probably also a reason why generic drugs are cheaper. Well, yeah, because as much to get to the stores, right, yeah, I think they can be

more profitable little at a lower cost. Right, And and they're also cheaper because at that point it's a longer monopoly, right, you can't. Now, they can undercut, right, they can undercut the the the main proprietor of said drug. Well, biosimilars are totally different, right, because we've just said a biosimilar drug can be completely structured in a different way than it's reference drug. Um it's supposed to do the same

thing pharmacologically, but structurally it could be very different. Because it could be very different, then there's the question of well, will this have different symptoms, will be have a different toxicity level than say, the reference drug does. It has to undergo much more extensive clinical trials than generics tend to.

So that is another reason why the cost difference between a biosimilar drug and the reference drug may not be as great as you would see in generic drugs, because you still have to undergo this incredibly exhaustive testing for good reason. I'm not I'm not suggesting that that's a bad idea. Sure, yeah, yeah, but but the but the market is still in play. You'll still have the effect of um of companies attempting to undercut each other's prices. Right, The question is just how far lower can they go?

Considering the fact that the UM the investment in biosimilars is generally speaking higher than it is to go into the business of designing generic drugs, or not designing but producing generic drugs. So let's let's talk about this idea of copyrights and patents because it does play directly into generics and biosimilars. It's not all science and technology, it's

also economics and intellectual property. Um. So when you start looking at large scale drug manufacturing, you have to go all the way back to the Revolutionary War here in the United States. That's when uh Andrew Craiggie begin established a manufacturing facility in Pennsylvania and he became the first Apothecary General of the United States. General. We don't have one of those anymore, we know he's entitled though. Yeah we got got rid of got rid of that shortly

after the Alchemist General. Um. But so by seventeen inventors were starting to file patents in the United States for medical devices and medicines. By the mid eighteen hundreds, companies began to form around new manufacturing practices, which at the time that was actually more important than the medicines themselves. The way you manufactured them became much more important than

whatever it was you were making uh. And the reason for that is that in the United States we were really dependent upon other parts of the world to actually research and develop medicines. Then what would happen is those entities, mostly in Europe, would essentially license the medicines into the United States where we could produce them here, but it was because somewhere else that's where that's where they were

being developed. So it was like an interesting thing to look at that that we weren't really developing drugs in the US at that time, we were simply producing them

based upon the work people in Europe were doing. So that actually became a bit of a problem because well by the end of the nineteenth century, German manufacturers were holding most of the patents around major medicines in the United States UM and in fact, there were subsidiary companies in the U S subsidiaries of those German companies that were producing the drugs here in the US, and they

didn't have the full recipe. Like it's like you would get a jar with you know ingredient X, and then you would you would go ahead and do the mixture as right, but you didn't know what was in ingredient X. Um, so it was kind of interesting that it was being kept as a sort of a trade secret, so even though it was being produced in the US, people in the U s didn't know what was going into it.

But okay, so we're we're coming out of the eighteen hundreds going into the nineteen hundreds, and lots of these companies were from Germany. Yeah. Yeah, so you're you're you're getting your you're thinking about like what have ends around oh, nineteen fourteen too, that you know, are somewhere around that range where you know, some conflict is happening in Europe. They they're entering into a you know, the war to

end all wars. Yeah, except you know, of course it didn't end all wars so much so that no one at the time called it World War One because they were all very optimistic. Um though, at any rate, world War one happens, and because it happens, it ends up creating a problem where the US is not able to access those drugs, those medicines that were coming from Germany anymore. The United States was trying to find ways to make certain that it wasn't providing financial support to Germany during

World War One. Sure, I'm sure that also some trade routes were a little bit disrupted by by the little bit seating. Yeah, so there was actually a lot past that that basically let Americans get around this, this entire thing. Yeah. Yeah, you get to a point where you're like, well, how do we how do we deliver upon medicines? How do we do this in this time of tribulation? What what

are our options? The United States government in nineteen seventeen passes the Trading with the Enemy Act and then actually allowed companies to produce products that were otherwise protected by patents if those patents were held by individuals or companies and enemy states. Its invenient. So right, like, your intellectual property doesn't count if you are at war with the United States and such a fascinating precedent. I love that. Yeah,

it's It's also the way I live my life. When I get into a spat with somebody, I'm just like, well, their ideas are no longer relevance, and I can I can take whatever they had. Well, now, so does this also mean that if somebody like physically assaults you, you can plagiarize their novel? I mean, that's how princip If that's accurate then I'm gonna I'm gonna go to go out to the writer events and like just start picking fights with people. So like, oh man, what are you

gonna do? Punch me, I'm gonna steal your short story. I think you're gonna need to be a little more specific with your wording because technically you can do that. You just can't get away. Uh. Yeah, you can't get away with it. But you you you could physically do that thing. Um. So we get through World War One, uh, and then we started getting into a new thought process in the United States. And this is what allows generic drugs to really become a thing. Back in the nineteen twenties.

It's a little company called Bayer, going back to aspirin. Uh. They were writing high on the headaches of the world, selling aspirate to whomever was ailing. But then you've got a lot of companies that were producing copycats. They essentially, you know, we're creating their own and we're making their own. Yeah, they're just making their own. Uh. Aspirin essentially or asked generic aspirin um and Bayer ended up going into litigious

actions suing lots of different companies and individuals. The courts in the United States, however, decide the Bayar couldn't demand stores to remove generic versions of aspirant to prevent them from being made or prevent them from being made. Rather, so then you get to the Second World War, and that also reinforced this idea that the United States really needed to invest in research and development of its own as far as medicines are concerned. It could no longer

depend upon outside sources to develop this medication. So they started to really, uh we see see a kind of a a boom in the pharmacological industry here in the US post World War two. Yeah, yeah, we all realized it was it's it's a national resource. It's it's important to be able to be able to fix our our populace. It's it's it was. It was essentially a type of national security, right, just like just like we talked about fuel in terms of national security today, medicine certainly fell

into that same category. Um. And you often will hear arguments similar to the US today about companies that develop a drug and of course they will protect that drug, and for the duration of that protection they can charge pretty much whatever they like, and there's not really any alternative to it. And you talk about things like, well that that seems really predatory. Well, during post World War two era, we were attempting to avoid a global version

of that. We still have the corporate version of that. So then you get into the idea of patents. Uh, now this we brought this up earlier, Joe. You mentioned patent medicine. Patent medicine ironically counterintuitive name, Yeah, ironically it doesn't have a patent. A patent medicine is usually what we call. You know, you had a snake oil sales and running around with a cart full of bottles of something called like you know, Uncle Uncle Jimmy's Cure Everything juice,

And I always think of a rheumatism, diarrhea and cancer. Yeah, fix it all and who turns out? What's in it is usually like alcohol and some turpentine or something. It always it always makes me think of a Doc Terminus from the movie Pete's Dragon, Uh, played by Jim Dale, an amazing Disney villain anyway, so he's not in the new one. I digress. I was on a Disney cruise,

so my mind is also still with Disney. Um. So, yeah, patent medicine was not patented and The reason it wasn't patented is that when you file for a patent, you have to explain what your invention is and how it works in general, and the idea being that if you've come up with an idea, and you that idea has the potential to benefit mankind as a whole, then by

filing for the patent one you've protected your idea. You you are supposed to be granted exclusive rights to that idea for a certain length of time, however long the patent is good for. Once that time expires, anyone can use the patent you have filed as the basis for their own work, and they can make their own version

of the thing you have invented. Yeah. So, so what you get into with with stuff like patent medicines is the idea that that you don't want anyone else to ever make the stuff that you just made, or at least or you don't want to have to prove that it works and that too. Yeah, yeah, one of the two, certainly, you know. For for example, I believe that the w D forty is still not patented because the makers of it just don't want anyone It's like a trade. Yeah.

So people who purveyors of patent medicine would claim that their medicines are trade secrets to they don't want the secret out because they are the ones who produce this miracle cure and uh and and they're doing so responsibly and you should buy from them. Meanwhile, patented medicines have actually gone through this process of being filed with a

patent office and being issued a patent. So patent medicine versus patented medicine, they're opposite of each other, which is hard to get your mind around when you first start reading about these sort of things. Also tells us that patent medicine it's a historical term. Yeah, yeah, yeah, although actually I wonder if some of the alternative medicines out there, um kind of fall into that same category. Yeah, I would imagine so well, and a lot of those alternative medicines.

You know, people say, well, this is not a drug. It has a chemical component in it that has a pharmacological effect. By definition, it's a drug. It's just an unregulated drug that you cannot guarantee that you will have the same amount of active ingredient from one dose to the next. I'd say most not legally speaking, but Yeah, most alternative medicines today probably don't have turpentine in them,

so they're less likely to make you violently sick. I do, Like you said, most and probably, but they might not be any more effect at any rate. You know this, This whole discussion of patent versus patented illustrates that language is dumb. Uh. Also, we can we should mention that drugs are not just necessarily protected by patents. Patents do expire after a given term like seven to twelve years, depending upon the place and the type of patent you're

talking about. Um, and sometimes some patents again, depending on where you are, could last longer than that. Uh. Drugs can also be protected by trademarks. Now, trademarks are not protecting the composition of the drug. It's really protecting the brand, the name, right, the name and perhaps the way that the bottle looks, stuff like that, Yes, exactly, or even

the design of the pill. Yeah exactly. So So if if what was our what was our fancy drug scalp SCALP, now that's the that's the patented version, well that would be they would also be the trademarked version. Yeah. Yeah, yeah, you can't call just any old q hi hyd Uh scalp extra right, you have to come up with another

scalp pun and you couldn't. You couldn't market it in a bottle that looked similar to a scalpex or bottle because most likely that would also be trademarks are too similar to similar, and trademark is one of those things that you have to defend in order to keep it. If you trademark something and you don't defend that trademark, then uh you can you won't have a whole lot of ground to stand on if you ultimately decide, hey, I've had enough of this, I'm going to go out

there and go after these guys. Yeah, I've heard that that's a common explanation for like, oh, why is some company being a jerk going after some small fish? You did some you know, little tiny trademark infringement. Uh, And I think it's sort of about legal precedent. They're afraid if some rival company seems that they haven't pursued trademark infringement rights against the small fish, then they have the precedent to take advantage of it at a large scale exactly.

So Uh. Again, once that exclusivity of the the patent expires and other companies are allowed to get into the game and use that same idea to make their own product. That's where you see generic drugs come in. In the chemical side of things, like the small molecule type of drugs. Uh, that's when generics can hit the market. It's also when biosimilars can hit the market. But the big difference here

is that when you're talking about a biosimilar drug. Uh, the people who make or the companies that make biologic therapies don't have to reveal everything that goes into making that therapy. And you mentioned this earlier, Yeah, because because when you write when when when you patent to this kind of thing, you're not necessarily patenting the process. You're patenting the resulting product. Um, you can separately patent to the process. Maybe sometimes depending on what machinery you've created

or stuff like that. But uh, but in general, since you're working with with living tissue and living systems and and stuff that is unpatentable like DNA, it falls into that trade secret category. Right. So then that means if you want to create a biosimilar, then what you have

to do is kind of work backward. You might know in general what goes into the biologic therapy, but in order to get to that destination, you may have to plot your own course, and thus you have to go through that big clinical testing because the the approach you take might be dramatically different from the approach the the producer of the reference drug took. So let's talk a little bit about the history of biosimilars. This was interesting to me too, because it went back further than I

had imagined when you start talking about biological therapies. So in the US, the government got involved with biologically derived products way back in nineteen o two with the Biologics Control Act nineteen o two. UH. And it actually was this This shouldn't really be much of a surprise. It was that response to a tragedy that had happened in

nineteen o one. There was a diph theory any toxin serum that was derived from the blood of horses, and unfortunately, one batch of that antitoxin serum caused the deaths of thirteen children. When there was an investigation to find out what caused this, UH, it went back to a St. Louis manufacturing company that had used the blood of a horse that had been infected with tetanus. So the Act was created specifically to put protections in place to prevent

that sort of thing from happening again in the future. Now, with a lot of these biologic therapies, a lot of them are are relatively young. I mean, they don't all date back to nineteen o two, right, so some of them are just getting to the age where those patents that were filed back when they were first developed are

expiring soon. That is another reason why this discussion of biosimilars has kind of popped up in the media, because we're now getting to a point where that protects and expires, and other companies can actually legally create their biosimilars to the biologic therapy, and recently it's happened with a couple of drugs I believe for for rheumatism, for for rheumatoid I. Threat is right, and this is still so new that we don't have a really well thought out policy that

that is specifically intended to regulate this sort of stuff. In the United States, biosimilars currently fall under the regulation of the FDA's Public Health Service Act, but there are motions to create a formalized approach to the testing and

approval to biosimilars. So right now, the way if the FDA treats this, it makes sense if you were listening earlier to the podcast, they treat it like every biosimilar is actually an entirely new biologic therapy, right so it's just the same as if you had come up with a brand new process to treat a specific illness or

set of symptoms. And so a lot of people are thinking, well, there's got to be a better way of doing this, and that in turn will one encourage more companies to develop biosimilars and to help bring that cost of the final therapies down, because if you're able to streamline this approach, uh, the investment on the end of the companies won't be

as great SUH. And I did want to also put in that not all biologic therapies fall under the regulations for for for this biosimilar drug kind of thing, like a like if if you if if you've ever taken insulin or birth control pills, then you know that those are regulated the same way that the chemical drugs are here here in the United States at any rate, and so so generics of those can be made and called

generics even though they're technically a biologic therapy. Uh and it's for a number of honestly exhausting legal reasons that those have been categorized that way. But yeah, So glancing again in the future, it looks like biosimilars are going to play an increasingly important role in medicine. It may, however, not lead to some sort of glorious renaissance of cheap therapies. Right,

we may see less expensive therapies. In fact, if we don't see less expensive therapies, they're gonna be some companies that are out of some serious money. Because the only reason to get into the game is if you can produce a a therapy that is effective for the treatment of a particular condition or illness or whatever at a lower selling cost than the the leading brand of that therapy.

Otherwise you're not you're not gonna sell anything. You're not gonna you don't have a you don't have something to entice people to buy your approach versus the name brand approach. So they will be cheaper. The question is will they be significantly cheaper, And they may not be. There are some people who are skeptical that it will be a

significant drop in price. So then we also have other complications such as how are they going to be affected through things like insurance, Like how how is insurance going to um cover a biosimilar versus the reference biologic therapy? And we don't have the answers to this yet. These are still questions that have to be solved. And keep in mind that we're talking about a realm of science that is still relatively young and is outpacing legal and

insurance realms. So it's gonna be messy for a while and it may not shake out for several years until we've reached a point where we have a better understanding on from all perspectives. Yeah. Yeah, if you're asking about the direct future of biosimilar as, I would say that it's something of a regulation headache at the current moment.

I mean, you know, partially for for the reasons of protecting um these companies interests, but also for the reasons of protecting doctors and patients as they come to understand how the products work and comprehend the potential risks and

using them versus a previous therapy that they have used. Right, So, ultimately, I think what we're going to see is that these therapies and similar therapies, these biologic therapies, whether it's the reference one or the the various bios similars out there, they're going to become more accessible and at least in theory,

they will become less expensive. Both of those are good things. Uh, It's just one of those deals where we really felt that a lot of that coverage out there was treating this so so much on a surface level that it's hard to understand why it's complicated until you start really diving into it, you realize, Oh, it's complicated because one

you're talking about biology, which is not necessarily simple. I mean, uh, you know, every time you work with a cell, you're not guaranteed have specifically the identical experience like you would with using the exact same chemicals in a pristine laboratory setting. Yeah. Sure.

And although the ingredients in in many biosimilar drugs, the proteins, the sugars, the DNA bits, any of that stuff is hypothetically a chemical and hypothetically can be reproduced consistently, you don't again, because you throw in that that you're doing stuff with living stuff factor. Yeah, living stuff can have slight differentiation from from instance to instant. Yes, so that

ends up being a bit of a complication. But then on top of that, you've got the complication of that where people and we have to figure out how to handle this new, relatively new discipline and uh. And so that's why it's so complicated, partially because we made it that way. But this was really interesting to look into.

I really learned a lot as I started to research this stuff that you know, I thought I knew, and then as I was reading, I'm like, wow, I had a complete Uh, I had the wrong perspective on this. You know, this topic makes me think that in the future, we should maybe do an episode entirely devoted to the future of medical research incentives, because the whole the thinking behind the patent system, as you said earlier, you know, part of it is about in the long term, sharing information,

but it's also about providing incentive for research. Right is saying that it's sort of giving you a guarantee that if you forge a path that is a productive path, you will reap rewards from it, and other people can't scoop your rewards away. Um, And so I wonder, I wonder if they're interesting trains of thought about what types of incentives for research will continue into the future. I mean, will you always have to have the same kind of promise from the market to make people invest the time

and money into life saving research. Well, and we could also have an interesting discussion about Salk and the polio vaccine, because there's the the infamous exchange where he developed the polio vaccine and he was asked who holds the patent on it? And he says, well, I I suppose the people hold the patent on it. I mean, would you

patent the sun? And so there are people who champion him as saying that this was a person who developed a uh an approach to stave off a devastating disease for the good of all humans, right, like an altruistic act, And the truth of the matter gets a little more muddy and complicated. But that would be a great side discussion for that particular episode, I would say, so keep an ear out for that in the future. Meanwhile, make sure that you go and check out the videos we've

been doing for Forward Thinking this season. I think that there's some of the strong ones we've produced so far. And uh if you have any suggestions for future episodes, or you have a question about something we've talked about in the past, send it our way. The email addresses f W Thinking at how Stuff Works dot com, or you can drop us the line on Twitter where FW thinking there, or search FW Thinking and Facebook. Our profile will pop up. You can leave us a message and

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