Pfizer grabs a solid endorsement from FDA insiders for their knockoff of Amgen’s flagship drug Epogen

Pfizer’s second attempt to win an FDA OK for Hospira’s biosimilar of Amgen’s fast-declining anemia drug, Epogen, is on course to a likely approval — with few or no fireworks planned for an upcoming panel review.

Rejected by the FDA back in the early biosimilar days of 2015, regulators started off their review by giving a clear nod to the second effort, which comes after the pharma giant acquired Hospira and its pipeline of knockoffs for $16 billion.

Usually in these regulatory reviews, the FDA likes to spotlight the hard issues that it wants its independent experts to debate. This time, they’re basically being asked to rubber stamp a determination that the copycat comes close enough to the original to warrant an approval.

In regulators’ words:

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. The analytical similarity assessment was conducted using multiple orthogonal physicochemical and functional methods. The results support a demonstration that “Epoetin Hospira” is highly similar to US-Epogen/Procrit based on analyses of primary and high order structure, glycosylation, biological activity, product related species, and stability profiles, including degradation products and degradation pathways.

Epogen has been a flagship product at Amgen for years now. But Novartis’ Sandoz and others were quick to start lining up cheaper biosimilars for it once developers got serious about the field. For Amgen, which has its own biosimilars in the pipeline, the move on Epogen puts growing pressure on a pharma company that needs to find new products to gin revenue.

Amgen had thought that its PCSK9 drug Repatha could help fill the gap, but payers have been throwing obstacles in its course, hampering sales efforts. Just a couple of days ago, Amgen was also handed a major setback on romosozumab, after investigators spotted a heightened risk on cardio events that will at least delay the program or possibly even kill it.

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Skyhawk Therapeutics Waltham, MA
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