Biosimilars

FDA experts wave through Pfizer’s copycat of an anemia med from Amgen, J&J, but a legal challenge still remains

Pfizer had no problem convincing an expert panel at the FDA that its biosimilar of Amgen’s blockbuster anemia med Epogen and Procrit, marketed by J&J, should get a quick green light for marketing.

The experts lined up 14 to 1 in favor of the approval, no big surprise given the agency’s clear endorsement in its written review from agency insiders. Their bottom line:

The totality of analytical data support the determination that “Epoetin Hospira” is highly similar to US-licensed Epogen/Procrit notwithstanding minor differences in clinically inactive components.

That would have been a difficult conclusion to buck by the panel, especially after the FDA had begun to routinely hand out approvals to new biosimilars in most cases.

Diem Nguyen, Pfizer

Amgen still has a trick or two up its sleeve though in protecting its longtime cash cow. The pharma company — sometimes described by wags as a law firm with a biopharma arm — sued Hospira in 2015 claiming that the company sent in a premature notice of commercial marketing on the product. Amgen’s lawyers said that the biosimilar infringed its patents and that the developer — acquired by Pfizer — should have waited until it received formal approval before it filed its 180-day notice.

Lawyers for Novartis’ Sandoz unit blasted back that Amgen was looking to create an extra period of exclusivity that lawmakers never intended with their legislation on this. The two sides have also been bickering whether a biosimilar manufacturer has to hand over its IP on the generic when it files its notice.

That argument is now being considered by the US Supreme Court.

Sooner or later, though, it appears that Pfizer is on track to start competing with the fast-fading franchise drug, which still brought in $1.3 billion last year.

“Following the approval and launch of Inflectra (infliximab-dyyb) in 2016, this positive recommendation – a first for a proposed ESA biosimilar – marks an important milestone for Pfizer’s U.S. biosimilars portfolio,” said Diem Nguyen, global president for the Americas at Pfizer.


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RAPS Regulatory Convergence 2017