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James Shehan, JD: The State of US Biosimilars Regulation


James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP, discusses the state of biosimilar regulation in the United States.


How would you characterize the state of biosimilar regulation today, and what have we learned from the first years of the Biologics Price Competition and Innovation Act (BPCIA)?

Biosimilar regulation, and this is something that I’ve been thinking about and active in for a long time in a previous role as head of government affairs at Novo Nordisk; we took a hand in shaping, you know, lobbying and negotiating, various pieces of the BPCIA.

It’s 2018, we have a law that’s been in effect 8 years, and I’d say only now are you finally starting to see real-world effects of the implementation. Fascinating, because you can always, as many people have, contrast it with Europe where they passed a law in the early aughts and within a year or 2 there were products on the market. And biosimilars to, I think, 7 different molecules by the time we passed our law and now they have many more. And we have a handful approved, and a very small number on the market. Patent challenges [are] holding up the others.

I think it is completely fair to say that FDA has been abominably slow in implementing the biosimilar law. The law puts significant hurdles in front of US biosimilars in order to get them to market. But that doesn’t mean that FDA had to take such a long time in rolling out guidances on some of these issues. And we’re still waiting, for example, on the guidance for interchangeability. I mean, not that much has changed scientifically in 8 years so what’s the hold up?

All that being said, there is a pipeline of products being worked on. I think you’ve seen some shakeout in the industry, you know you’ve got a little bit of a gold rush mentality early on and a lot of smaller players getting in who really don’t have the capacity, the capital, or personnel to solve the challenge—the rather difficult logistical challenge of developing a biosimilar. It’s essentially an effort that’s equivalent to bringing a new drug to market. So, you’re seeing some of those smaller companies going away, I saw Momenta recently laid off a bunch of their staff. It looks like a skeleton crew now, and they were a prominent early player, and there’s other examples like that.

You’re essentially seeing the big established industry—with a couple of newcomers like the biotech arm of Samsung playing a role—and litigation being an ongoing challenge to anyone trying to bring a product to market. See for example the Humira biosimilars that are approved and will not be launched until 2023 under various settlements with AbbVie.

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