“A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness….”
– FDA website
Though the biosimilar market is still young, the number of companies working on biosimilar products is growing, putting pressure on regulators to make decisions on how they get approved—and on makers of the reference products on which they are based to ensure their intellectual property and market share are protected. Discussing these issues are Phil Katz, partner and head of Hogan Lovells’ FDA Pharmaceutical and Biotechnology group in the Washington, D.C., office; and Stephen Bennett, an IP partner in the London office.
What are your areas of specialty?
Phil: I work with pharmaceutical companies on regulatory issues in front of the FDA, primarily getting products approved and managing their life cycle.
Stephen: My areas of specialization are in pharma patent litigation, where I represent innovators defending their monopolies and extending their intellectual property rights.
What are the differences in the biosimilar markets in the U.S. and the U.K.?
Phil: In the U.S. it’s a time of great excitement, yet also some apprehension. We’re in the early stages of getting biosimilar products approved and there are still a lot of questions to be answered by the courts and the FDA. So there are a lot of companies involved but also uncertainty about how it’s all going to play out.
Stephen: The biosimilars industry in Europe has been off and running for a while. We’ve seen much bigger players come into the market and there is a lot of product in the pipeline. But as elsewhere there are issues that need to be ironed out, so it’s too early to tell how successful these products will be.
Can you describe some of these issues?
Stephen: Biosimilars work the same as their reference products but they are made differently and those differences are where a lot of the legal issues arise. Is it similar enough to get approved? Are the differences relevant for patients? If one product is prescribed should pharmacists be able to interchange the biosimilar for the originator? These have yet to be decided.
Phil: As Stephen said, there is the bottom line threshold of biosimilarity, and then there are questions about the various indications for a drug; can you extrapolate similarity in one indication to a similarity in other indications? This is essential for labeling and prescribing.
Makers of biosimilars and makers of reference products: what do they each need to know?
Phil: The benefit of the biosimilars law is a shorter application process because you are relying on your similarity to an already-approved product. But you may still have a fairly long development period, so you need to take that into consideration. And because there’s so much still to be decided, your development strategy should include early consultation with FDA.
Stephen: We help makers of reference products to defend their patents and to interact appropriately and effectively with the biosimilar and with regulators to make sure that the appropriate standards are applied. [this does not seem to answer the question. On the day, I think I said something about the longer timelines involved and the need to plan further ahead – that sits better]
Watch this video for additional insights from Katz and Bennett on the emerging issues in the biosimilar market.