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Robert Cerwinski: Reference Product Sponsors and Biosimilar Development


Robert Cerwinski, JD, partner at Goodwin, discusses the challenges that reference product sponsors encounter when they also seek to develop biosimilars.


A very interesting question. What we see in the biosimilar space that we don’t see as often in the generic drug space are brand companies really aggressively pursuing biosimilars of competitor products. We do see companies like Amgen play both sides of the fence. We also see that, at least with respect to questions like “what are the requirements of the patent dance? Is it mandatory, is it not?”, Amgen has really had to be very careful in the line in takes.

As a biosimilar defendant, where the economic imperative is to get to market as fast as possible, whereas on the branded side every day of delay, every month of delay represents an economic advantage. We do see currently that companies that are playing both sides of the fence have to be very, very careful. Since a biosimilar can be quite profitable though, and since biosimilars present one way for branded companies to compete against their other branded competitors, I don’t think Amgen will be alone. I think we will continue to see branded companies really vigorously pursue biosimilar opportunities of competitor products.

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