Biosimilars: Are We on the Edge of a New Era of Biologics?

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Luca Mantovani, CEO, INFA Group

A: DEFINITELY, YES. Imagine that 10 years ago, even 5 years ago, there was a lot of discussion about biosimilars but there was not really a successful breakthrough. I expect that now biosimilars will gain, in the next 5-10 years, strong traction and I see several companies which are jumping into biosimilar development. Government bodies will also play a role by subsidizing these developments, [and] having biosimilars is definitely an opportunity to [also] reduce the costs in this area.

 

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Stephan Kutzer, CEO, Alcami

A: When it comes to labeling biologic copies of patented large molecule drugs, perhaps ‘Biosimilars’ is the wrong term. In reality, under the current regulatory frame, creating a biosimilar and getting it approved requires nearly the same expense and effort it takes to take a new biologic NDA from lab to patient. Much of biosimilars’ market potential will depend on insurers’ willingness to accept and pay for these medications. Another big question is whether or not prescribing doctors will trust and recommend biosimilar medications to their patients. Will there be enough competition is another question; the current generics economy sees several companies competing over the sales of a single compound, and that generates pressure that helps keep prices low — the main reason for generic equivalents. Even the rosiest predictions project only a few major players will participate in the near term. Because of that, and other factors, it’s likely that pricing will be ‘similar’ to current biologics pricing, and we won’t experience the price differential that made small-molecule generics so popular.

 

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Greg Flyte, Head of CMO Alliance & Program Management; GlaxoSmithKline

A: I think, with respect to biosimilars, we’ve sort of already seen some of this play out with the initial approvals in the biosimilar space. If I think back [to] 3-4 years ago, we saw what I’ll call a flurry of activity from a lot of smaller companies that were attempting to participate in this space, [but] over the last 1-2 years, I’ve seen that drop off and [become] more focused on the more prominent players both in the pharma and the biopharm space. So I think what people are seeing is that the ‘gold rush’ isn’t as easy as what some thought it may have been early on in the process and that getting a biosimilar approved is just as difficult and maybe, in a lot of instances, more difficult than an innovative product approval. The answer to the question is [also] a little bit different if you’re talking about the U.S. versus Europe, given that [Europe has] had biosimilars on the market for 10+ years, but the US is just coming to the forefront now. Government pricing pressures, the regulatory and legal landscape, and global, large-scale capacity constraints are all significant factors that will influence the impact of biosimilar penetration in US markets.

 

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Franck Pavan, CDMO Department Manager, Injection products, Pierre FABRE

A: Yes, I think so, but this is exactly the beginning. There are currently big players which are not known to be players in the pharmaceutical industry but which have invested a lot in the manufacturing of the monoclonal antibodies, which are needed for biosimilar products. I think it’s the beginning of great success because there is a big market for biosimilars. The companies that own the patented registered products have moved to these technologies in the 1980s and 1990s, and have made a lot of big improvements in the way they are manufacturing; nowadays, they are moving to the next steps with the new entities that they want to use for new treatments to maintain their profits. I think that the price for biosimilars won’t be as cheap as it would be for standard generics because of the technology and the clinical studies that need to be implemented in order to support market introduction. There are a lot of patents which are moving out of licensed environments, and the technologies to manufacture the antibodies and the biosimilars are already available; they just need to be transferred from their production areas once the patent has expired. I think we are moving to another generation of biosimilars, which will be manufactured in highly regulated countries to support the new regulatory environment for market entry.

 

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Kristof Szent-Ivanyi, Business Development Head, GSK Biopharmaceuticals

A: It’s a booming industry, and increasingly attractive to both drug innovators and generics Companies. But the large-molecule market space will likely not ever be as crowded as it is in the small-molecule space. For one, barriers to entry can be quite high, and it’s well-known that it takes a much different set of technical and operational skills to be successful. Even though there are a number of innovative therapeutic large molecule pharmaceuticals that could potentially be replicated, not all of them are feasible as biosimilar candidates. A biosimilar developer can spend as much as £300 million to develop a large molecule drug; the choice of what molecule to develop is highly dependent on the drug’s market potential, as well as opportunities to duplicate it more economically and without effecting the therapeutic effectiveness of the originally patented molecule. The bottom line is some formulations are quite advanced, and for anyone pursuing a biosimilar strategy, it takes advanced knowledge to get it right. GSK’s contract manufacturing arm helps companies to develop and manufacture their biosimilar products.

 

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Bill Marth, President and Chief Executive Officer, Albany Molecular Research

A: There’s going to be great opportunity in the biosimilar market; however, that potential is predicated on how well the FDA and its international peers frame law and policy to guide the industry. The pathway has been defined; but now it’s time to refine the pathway such that we unleash innovation and competition in this area.

We believe this a segment that will grow exponentially over the next decade and that growth is guiding AMRI’s strategic planning in very distinct ways. Developers
and manufacturers, like AMRI, will need to be able to field the science, services and operations to support this coming demand and we plan to be right there.

 

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Mark Bamforth, President and CEO, Brammer Bio

A: The economics of biosimilars is not at all similar to current small-molecule generic drugs — which are often steeply discounted from the innovator. Frankly, what biosimilars represent to the marketplace is not a “generic” per se; they really are a “new” branded product. Because of that, we see an increased number of larger biotech companies entering the biosimilar arena and working to leverage their considerable resources to produce formerly patent-protected large molecule biopharmaceuticals. What will the biosimilars’ landscape look like in the next 10 years? It’s likely that there will only be a handful of ‘expert’ producers manufacturing biosimilar drugs, and while economies of scale and operational expertise will likelyhelp cut manufacturing costs, these economics will likely not translate into the savings that have been generated over the years for consumers of small-molecule medicines. The depth of penetration of biosimilars can be transformed if regulators accept the substitutability of biosimilars — that will ultimately drive the kind of prescription momentum to open the doors of the category wide open.

 

Guy Tiene

Guy supports the success of life science organizations by identifying synergies across research, content, marketing and communications resources to drive value for clients. With over 30 years of education and marketing experience and 18 years in the life sciences alone, Guy leads our editorial standards for client content, Pharma’s Almanac and Nice Insight research-based industry content as well as external communications for clients. Having served as head of global marketing and communications for a CMO, he also brings critical insight and guidance to all communications. Guy holds a Masters degree from Columbia University.