Drug Development

FDA offers Novartis a thumbs-up on Enbrel biosimilar as Amgen plays offense/defense simultaneously

On Friday, the FDA gave Amgen a clean bill of health for its biosimilar of AbbVie’s Humira. Today, it’s Amgen’s turn to watch a megablockbuster go under the biosimilar gun, as the FDA offers a clear thumbs up to Novartis’ knockoff of the $9 billion drug Enbrel.

Two days ahead of a panel review, FDA insiders said that Novartis’ generics division Sandoz had offered all the data needed to conclude that the copycat was good for all indications Amgen sells Enbrel for in the U.S. The FDA’s insider conclusion:

“In considering the totality of the evidence, the data submitted by Sandoz show that GP2015 is highly similar to US-licensed Enbrel, notwithstanding minor differences in clinically inactive components, and that there are no clinically meaningful differences between GP2015 and US-licensed Enbrel in terms of the safety, purity, and potency of the product to support the demonstration that GP2015 is biosimilar to the US-licensed Enbrel in the studied indication of PsO. The Applicant has also provided an extensive data package to address the scientific considerations for extrapolation of data to support biosimilarity to other conditions of use and potential licensure of GP2015 for each of the indications for which US-licensed Enbrel is currently licensed and for which GP2015 is eligible for licensure.”

The decision, which is likely to pave the way to a quick approval, is a mirror reflection of the FDA’s view of Amgen’s Humira biosimilar, which threatens AbbVie’s $14 billion franchise. But where Amgen is fighting to get its biosimilar on the market, it’s fighting tooth and nail against Novartis, waging a legal war against Novartis’ development strategy, which studied the drug only for psoriasis but is looking for an approval on a full slate of indications.

In this case, the FDA doesn’t have a problem with indication extrapolation, as it is called, but depending whether you’re playing offense or defense, it’s a flash point on the legal front.

These back-to-back biosimilar applications mark a new stage in the field. Novartis won a pioneering approval for the first biosimilar with Zarxio, a knockoff of filgrastim, and has its eyes on Humira and other aging blockbusters. The agency clearly has its doors open to these big players who are threatening to topple some of the most lucrative drug franchises in the world. And the first wave of applications are blazing a trail for others to follow. But in the end, the near-term prospects for the field may be limited if the companies playing defense can prevail in the courts and protect their patents for years to come.

The jury is still out on that, but the FDA is making its position crystal clear.

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