Print BCTV: Biosimilars -- Amgen, Momenta on biosimilar naming, substitutability


Transcript of BioCentury This Week TV Episode 178



Geoff Eich, Executive Director R&D Policy, Amgen

Craig Wheeler, President and CEO, Momenta Pharmaceuticals

Brian J. Malkin, Partner, Frommer Lawrence & Haug LLC



Federal Trade Commission

Food & Drug Administration

United States Pharmacopeia

Aetna Inc.

Hospira Inc.

Novartis AG's Sandoz unit



Steve Usdin, Senior Editor



STEVE USDIN: Biosimilars, lower cost versions of expensive biologics, are coming to American pharmacy shelves, and drug companies are battling each other over the rules of the road. The safety of millions of patients and hundreds of billions of dollars are at stake. I'm Steve Usdin. Welcome to BioCentury This Week.


NARRATOR: Connecting patients, scientists, innovators, and policymakers to the future of medicine. BioCentury This Week.


The U.S. is finalizing the rules of the road for biosimilars, lower cost versions of expensive biologic drugs for diseases like arthritis and kidney failure. This means blockbuster innovator biologics will face competition, which promises to save consumers billions.


Biosimilars companies disagree about how they should compete. One camp is pushing for rules that would make it possible to sell some biosimilars like inexpensive generic drugs. The other camp is gearing up to market biosimilars just like branded drugs.


Meanwhile, healthcare providers and insurers say expensive biologics are the elephant in the room. They're campaigning for laws and regulations they hope can bring $250 billion in savings from biosimilars over the next decade.


STEVE USDIN: To get two very different visions for biosimilars, we'll hear from Amgen, a big biotech company that's developing biosimilars, and from a smaller biosimilars player, Momenta Pharmaceuticals. First to help explain the policies the two sides are fighting over, I'm pleased to be joined by Brian Malkin of Frommer Lawrence & Haug.


Brian, you were at the recent FTC meeting where there was a discussion of two issues -- state substitution legislation and naming of biosimilars. Let's start with the state substitution legislation. Why is that legislation needed in the first place?


BRIAN MALKIN: There's a need for state substitution to facilitate substitution for biosimilars for the referenced innovator's product.


STEVE USDIN: So the idea is that there are going to be some products that are going to be interchangeable with an original product, and in order for a retail pharmacist to make that substitution, there needs to be some legislation in place, right?


BRIAN MALKIN: Right. And from FDA's perspective, an interchangeable biosimilar can be substituted without the intervention of the physician, the prescriber. But for biosimilars that are not interchangeable, there would need to be some intervention.


STEVE USDIN: So one of the issues about that state legislation is whether the pharmacist has to notify the prescribing physician of a substitution. Why is that a concern to some companies, and why do some companies think that it's a necessity?


BRIAN MALKIN: So it's a concern because of the fear that this will prevent substitution of some of the biosimilars if a physician needs to be consulted, because physicians typically do not like to be consulted prior to prescribing and the dispensing of a biosimilar or a prescription. And the reason why they would like to have it done in terms of letting the prescriber know is so they can go into the medical record potentially of the patient so they know whether they're getting the biosimilar or the innovator's product.


STEVE USDIN: So kind of on one side of it, there are people who think that it might be some kind of an impediment to prescribing biosimilars. On the other hand, they say, well, you need that information in the record. Where do we stand in terms of state legislation? There are, what, a handful of states already that have passed bills?


BRIAN MALKIN: Right. There are about a handful that have passed bills in terms of the state notification.


STEVE USDIN: And we're not talking about the whole universe of biosimilars here, are we, right?


BRIAN MALKIN: I think the concern is more about the interchangeable biosimilars. For biosimilars that have not been deemed interchangeable by FDA, I think most people think that physicians would be consulted or be part of the process in terms of whether that would be substituted. Interchangeable does not require by the law to have intervention of the physician.


STEVE USDIN: And it's also limited to the kind of biologic interchangeables that are going to be dispensed by retail pharmacies, and that's also a very small subset of the whole biosimilars universe.


BRIAN MALKIN: That's right. At the meeting, I think 5% was mentioned as the number of --


STEVE USDIN: So the other issue that was discussed, and there was a lot of debate about it, is the name. What is the issue there?


BRIAN MALKIN: So, I think on the one hand, the biosimilar manufacturer of some of them would like to have the name to be the same, the non-proprietary name to be the same, to facilitate uptake of the biosimilars, even if they're not interchangeable potentially. And in fact, pharmacists have filed a petition with the FDA asking for some guidance in this nature of what to do.


On the other hand, if the names are different, the FDA has spoken or has intimated that if there would be differences let's say in glycosylation or some other part of the biosimilar, that that might be included in the name. They've done that historically. But if the differences are more minor, then there may not be any difference in the name.


STEVE USDIN: And this is, we're talking about the non-proprietary name. So that's not the branded name. That's kind of the second name that goes after it. And there's an expectation that the branded name would be distinct. The real concern here is over the non-proprietary name, right?


BRIAN MALKIN: That's correct.


STEVE USDIN: And what would be the reasons again why companies might want to have a different non-proprietary name for a biosimilar?


BRIAN MALKIN: If there is a different name, then it would make the substitution of the product more difficult on the one hand. It would also might provide some additional detail about the product that might be of some use.


STEVE USDIN: And some people point to the experience in Europe, and they say well in Europe, these non-proprietary names are not changed. They're shared by products. So it's not really necessary to have that kind of a change here.


You were at FDA for about a decade. Where do you think they're going to come out on this?


BRIAN MALKIN: That's a good question. I think FDA is taking all of the information in right now and trying to make the best decision. The concern really comes down to pharmacovigilance in my mind in terms of safety. And so if the names are different, is that going to help in terms of identifying whether a patient received the innovator's product or the biosimilar version of it, or will it not be necessary because all of the biosimilar applicants or sponsors are going to have their own proprietary names, as they do in Europe right now.


STEVE USDIN: Who's going to make that decision about the naming of biosimilars in the United States?


BRIAN MALKIN: That's probably going to be a consensus. FDA is going to be part of the process. And they'll do it in collaboration with the USP and other authorities.


STEVE USDIN: USP meaning US Pharmacopoeia.




STEVE USDIN: There was also some discussion at the meeting of really what the FTC's role, the Federal Trade Commission's role -- what role do they have in all of this?


BRIAN MALKIN: The FTC is really concerned about competition. And so they're concern, as they've outlined from having this workshop in the first place, was that even before there's a first biosimilar that may be approved, there's the potential that the state substitution laws could make it difficult for that state substitution to take place. Because the physician needs to be notified prior to dispensing the product, and it may never happen.


STEVE USDIN: Great. Well, thanks. Thanks very much. We'll be right back with Amgen's point of view. First, here's why Aetna says a competitive biosimilars market is needed to prevent specialty biologics from breaking the bank.


NARRATOR: You're watching BioCentury This Week.




STEVE USDIN: I'm pleased to be joined by Amgen's Geoff Eich. Geoff, the biosimilar industry has been characterized by these intense conflicts over just about everything, because we're creating or you're creating a new playing field for a whole new industry. And one of the sets of conflicts has been around state legislation on substitution. And my understanding is that Amgen and some of the companies that have been opposed to its positions have come up with an agreement.


Can you talk about that, what it is and why it's important?


GEOFFREY EICH: I think it is a new era and a new class of products. And we're very excited about bringing our six biosimilars to market. Obviously we're a pioneer in the biotech industry. And for us, this is a new space.


But it's also very exciting from both the scientific perspective and also looking at how we can increase access for patients. So on the topic of some of the state legislation, one of the things that we think is most important for biosimilars and to be really successful in the market is to ensure that both patients and physicians have confidence in these medicines, that they understand the basis on which they're approved and also know that we're accountable for the medicines.


So that really has much to do obviously with the federal law and the way the FDA will approve these medicines. And we have great confidence in that. Another component, though, is whether and how we will have records of which medicines each patient has received. And so those medicines and those records are actually a matter of state jurisdiction in each of the 50 states.


STEVE USDIN: One of the things that's happened is that different states -- and the most prominent one recently was California -- enacted legislation that would say that if a pharmacist were to substitute a product that was considered interchangeable, the FDA said was interchangeable biologic, for another biologic, that they would notify the physicians. And some of the companies are developing biosimilars. And some of the public advocates on this oppose that, and they persuaded the governor to veto it.


And Amgen was for that legislation. What would be changed now in the agreement you've gotten for going forward?


GEOFFREY EICH: Well I think California was a really good example of where we can work together and find consensus approaches that can be acceptable and frankly, quite exciting for everyone in the healthcare space. California had a very neat approach, which was to ensure that where the pharmacy has discretion in terms of which product is selected for a patient, that that information is communicated to and within the healthcare team.


Now, the approach in California was really, I think, pretty neat in the sense that it said, for any and all biologics. And that's been a fundamental principle is, that a biosimilar is another pathway to approval. But once approved by FDA, a biosimilar has all the attendant rights and privileges of any other medicine for the indications that it's approved. And also, it has all the same sensitivities of any other biologic medicine.


And so the approach in California was to say, regardless of the kind of medicine that's selected by the pharmacist, let's ensure that the patient, the physician, and the pharmacist all know which product has been administered.


STEVE USDIN: And so you had opposition on that. Part of the opposition to it was the idea that you were somehow stigmatizing interchangeable biologics or biosimilars. What's changed in the agreement you've got now with some of the other companies, with Hospira and Sandoz, for example?


GEOFFREY EICH: I think it's the natural evolution of a conversation. So we've really worked hard and many others have in the physician groups, the patient stakeholders, pharmacists, and others to have a dialogue to understand what's important from the patient perspective, what's important to ensure that we're accountable for the medicines. And the number one thing is to ensure that all biologics are treated equally.


And I think that's been one of the fundamental enablers of increased support for these provisions is that it treats all biologics equally. And that's what we think is a bedrock principle. It really ensures that we're doing the right thing for patients. That's our grounding principle.


STEVE USDIN: So one of the other things -- and this is part of it -- that's going to be essential for biosimilars to be successful, as you say, is going to be confidence in their safety, confidence that they do what they're supposed to do. Very quickly, we just got a few more seconds left, but what are some of the other elements that need to happen to get that confidence?


GEOFFREY EICH: I think one is to ensure that every patient, physician, and pharmacist knows which medicine they've received and that we are able to track in the post market setting that the medicines are working the way that they're supposed to. That's not a question of how they're approved. It's just simply ensuring that each patient response is monitored. And if we can do that, we can be accountable to patients.


STEVE USDIN: One of the big issues about biosimilars is naming. There's a tremendous controversy about it. Who cares? Why is the name important?


GEOFFREY EICH: I think the one first and most important thing is that for biosimilars to be successful, patients have to have physicians and patients have to have confidence in these medicines. And so the way that they're labeled, the transparent data in the label, the way that they're named, that the name for a distinguishable substance is also distinguishable, and the way that the records are kept all play together to really ensure that we can be accountable to the patients we serve. So naming is a really important part of that.


STEVE USDIN: So there are two different kinds of names for drugs. Typically there's a brand name, and then there's a non-proprietary name. The controversy is about that second kind of name, right?


GEOFFREY EICH: That's right.


STEVE USDIN: What is at that Amgen's proposing, and why do you think that it's important?


GEOFFREY EICH: What we've advocated for and what we believe very strongly in is that a biosimilar medicine should share a common root, if you will, with the reference product but have a distinguishing feature. And we really don't have a strong perspective based on individual preferences whether that is a prefix or a suffix. But the idea is that the product, which is a distinguishable product, not just from the reference product, but three biosimilars may be distinguishable from each other as well in terms of their label but also in their structure, that those can be identified throughout the healthcare system.


And so non-proprietary naming is something that's very, very important for use in in prescribing in hospitals, using order entry systems and others.


STEVE USDIN: Basically you're talking about having a common name for the biosimilar and for the product that it's a version of, but also having some kind of a suffix or prefix on the biosimilar version that would identify it. Some of the manufacturers of biosimilars say is that's a way of kind of flagging biosimilars as being different and emphasizing the difference and that that will be used as a tool to market against them.


GEOFFREY EICH: Well, I mean, obviously we're developing biosimilars. And we feel very strongly that it is the best way to describe our medicine, which is that it has a common set of features with its reference product. But it's also a distinguishable and unique product in its own right.


And so I think from this perspective, what we're hoping is that the use of a common feature allows for us to look at medicines in the post-market setting across the class and to be able to aggregate data where it's appropriate to do so but also to disaggregate data where it's appropriate to do so. And there are going to be circumstances where an individual product may have its own set of concerns or frankly, well after its approval, could just simply have a quality issue. We want to be accountable for our medicines.


STEVE USDIN: Thanks. We'll be right back to discuss some other issues that are critical for creating a biosimilars industry.






NARRATOR: Now, back to BioCentury This Week.


STEVE USDIN: We're joined now by Craig Wheeler, CEO of Momenta Pharmaceuticals, which has been at the forefront of the biosimilars movement in the United States. Craig, to start with, I wanted to ask you whether you think it's possible to create a biologic that's interchangeable with another product that could be substituted for it just like a generic drug can be substituted for another drug?


CRAIG WHEELER: Sure, Steven. First, let me thank you for having me on the program here. Obviously, we would believe that because we've built our company around trying to make interchangeable products. But let me go back and just review some of the reasons why we think these are possible. It really is going to require innovation in terms of process, and in terms of analytics, and in terms of understanding the biology of these drugs. But the goals and the incentives to do that are there for companies like ours and others. And we believe the benefits for the patients are there as well.


So it is a matter of time, and it is a matter of science, but we do believe that it will happen. The FDA as well has foreseen this. And the rules they have put in place so far, they basically have given pathways for analytics to be able to drive to that direction, as well as clinical trials and efforts to bring biosimilars to the market, and then potentially in the future convert them to interchangeables.


So I think the science is here. I think the regulatory environment is prime for it. I think it will be possible.


STEVE USDIN: So one of the things that needs to happen in order for a patient to get biologic drugs from retail pharmacies, to have them substituted, is some kind of state legislation. And there's a controversy about the state legislation because some companies have suggested, and some other groups have suggested that the pharmacists should notify physicians if an interchangeable biologic is substituted. What's your thought about that?


CRAIG WHEELER: It's a broad set of issues that have come to play in terms of all of the different lobbying and company positions that have happened across this whole biosimilars environment. It started off in Congress, and it went to the FDA, and now it's in the states. And obviously, you'd expect companies to actually position themselves for what works best for them as companies. But you'll actually find at the state level that there's more alignment than not between all of the different companies, whether they be brand companies or biosimilars companies in terms of what they're trying to achieve in the states.


In the states, you do have to have legislation, because it is required at the state level to allow prescribing and substitution. And so the debate really is down to one aspect of what people are asking for in the state legislation, which is at this point in time notification of physicians when an interchangeable biologic is prescribed.


Our view on it is that this is not a necessary activity, because the physicians today already have access to knowledge about what they're prescribing for their patients, and they have technologies that are available to them should they actually desire to have a deeper understanding of what was substituted. Or in many cases, what's more important is what other drugs patients were on, because many of these adverse events that people are purportedly trying to prevent are actually drug-drug interactions and not problems with specific products.


STEVE USDIN: So at the FTC meeting, your chief counsel went a little bit farther than saying it's not necessary. He said it would actually constitute a kind of disparagement of the interchangeable biologics. Is that the way that you see it also?


CRAIG WHEELER: Well, disparagement may be a strong word. But we do feel that the competitive consequences to companies that are trying to make interchangeable products could be adverse. And there's a number of reasons for that. On the first case, the legislation that's been proposed is notification for interchangeable biologics only. Now if you think about that at the FDA, this is the highest bar that the FDA has set. And that was the first question you asked. I think it is really going to be a very high bar for FDA to actually approve these products, with the goal of, as the law states, giving the pharmacist the right to exchange these products at the pharmacy.


So when you put in a notification, what you're doing is you're actually, after a physician has been used to using biosimilar products that aren't interchangeable for many years, all of the sudden notifying them that, hey, here's an interchangeable product. And it's bound to raise questions.


I think the second implication is that the pharmacy who's having to implement this has disincentive to do that. It creates paperwork for pharmacies. It is going to be very, very difficult for them to understand who specifically they have to notify or not, because who's going to be using electronic medical records, and what systems, et cetera. And with the fear that this might actually create a bias in physicians. You may be even find pharmacies not willing to prescribe these until pre-notification because they don't want to have the risk of return of those products. So there's a number of reasons that we're quite concerned about the post-notification.


STEVE USDIN: Thanks. I want to get on to this issue of naming of biosimilars. We'll get back to that with Craig Wheeler in just a moment.


NARRATOR: Every month, BioCentury This Week will feature profiles in innovation, a special segment highlighting the stories of innovators whose work is improving lives and transforming the world of healthcare.




STEVE USDIN: We're back with Craig Wheeler from Momenta, discussing the future of biosimilars. Craig, the other issue that was discussed at the FTC meeting recently was naming of biosimilars. Some of the companies there made the proposal that biosimilars and interchangeable biologics should have a distinct non-proprietary name. What's Momenta's view on that?


CRAIG WHEELER: Well, our view is that many companies may want to do that. But requiring companies to have unique names requires them to actually build marketing sales forces and actually develop a brand name that is recognizable in the marketplace. We view the need to have different names as one, again, which could be conceived as anti-competitive, where the companies that actually are building the commercial infrastructure are looking to make sure that companies that have interchangeability don't actually get their products known into the marketplace because of the brand names, as opposed to having the same names as the existing brand drugs.


STEVE USDIN: So one of the arguments that's made by some of those companies, and also by some advocacy organizations, is that distinct non-proprietary names are needed in order to be able to track interchangeable biosimilars or regular biosimilars once they've been introduced into the marketplace. So if there's an adverse event, you can know exactly which drug caused it.


CRAIG WHEELER: Yeah, well, this is similar for generics that exist today. And all generics, first of all, have identification of the companies. And so having the same name, but also having the name the company, is no problem, because they're already labeling with the company that's producing it on the labels.


And so that really is one where you don't need to have a different name, but you have to have identification of a company. So we think that's fine. It's important, though, that for these interchangeable products in particular, you have the same identification number and -- I mean, not the proprietary name.


You can actually look to the pharmacy, and you're already tracking all of these products at the pharmacy level -- not just on the manufacturer, but the actual lot the product came from. So we see that the current naming system with the brand names on the labels, which they already are, and then using the tracking numbers at the pharmacy to be able to actually understand exactly what product and what lot they came from, if there was a problem, is sufficient to be able to ensure safety.


STEVE USDIN: So I want to get back to what you just said a moment ago though, that really part of it is about different business models that the companies have, isn't it? And Momenta's business model is to create something that's very much like the generic industry for interchangeable biologics, isn't it?


CRAIG WHEELER: Well, I think in the long term, that's our view of how the business is going to evolve. And so our lobbying positions typically are positions that are trying to make sure that different business models aren't legislated into existence. We feel, ultimately, that this will become much more like a traditional generic marketplace.


We also feel that in the short-to-medium term is we actually get experience with this technology. We may well ourselves have an opportunity to brand our products. But we also see a world out there where these are very, very high-priced products. And you expect the healthcare pressures to push these to more generic-type pricing.


And you would think that's also in the interest of what's happening in healthcare today. And so as you see those prices come down, you don't want to have to force companies to have proprietary brand names that they have to build, and large sales forces, and the like. You want to have people to be able to build low-cost structures, so they can actually ensure low costs for the public for these products. And so that's how we view our positioning in many of these issues.


STEVE USDIN: We've just got a few seconds left. Very briefly, what kind of price breaks do you think that the public can expect from interchangeable biologics down the road?


CRAIG WHEELER: Well, I think early on you're going to see price breaks that are relatively modest. But still, because these products are so high priced, 30%, or those types of numbers. But ultimately, you could see much, much more significant decreases as more competitors get to the marketplace, as people get more comfortable with the technologies allowing them to get approved. And so we look forward in the long-term to being a successful competitor in both of those different marketplaces as they evolve.


STEVE USDIN: Well, thanks very much. That's this week's show. I'd like to thank my guests, Brian Malkin, Geoff Eich, and Craig Wheeler. Remember to share your thoughts about today's show on Twitter.


Join the conversation by using the hashtag #BioCenturyTV. I'm Steve Usdin. Thanks for watching.