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Pfizer finally finishes a 3-year regulatory odyssey, bagging an FDA OK for 1st Epogen knockoff

A decade after Hospira launched its biosimilar of Amgen’s aging anemia drug Epogen in Europe, its successors at Pfizer have finally pushed it over the finish line at the FDA. The approval of the first Epogen copycat today — sold by J&J as Procrit — comes after their knockoff Retacrit was snubbed twice at the FDA, first in 2015 and again last summer, when regulators voiced dissatisfaction with their manufacturing center.

Leah Christl

The regulatory pathway proved much longer and harder than Pfizer anticipated when it bought Hospira in 2015. But the pharma giant has been plugging away, joining Novartis, Celltrion and Amgen itself as they advanced various generic copies of first-generation biologics to the FDA. 

Under commissioner Scott Gottlieb, the FDA has voiced its willingness to help move things along as efficiently as possible, but that hasn’t prevented a series of rejections over the past few years.

Epogen was first approved by the FDA in 1989, creating a franchise that sustained Amgen as it developed Big Pharma status. And Amgen continued to wage a long-running legal battle to delay the arrival of Retacrit, even though in the long run it didn’t need to. The FDA accomplished that task on its own.

Even as the European rival ate into Epogen’s revenue and Amgen lowered prices, it’s been a durable blockbuster, earning a little more than a billion dollars last year after garnering about $1.3 billion in 2016. But its blockbuster days are numbered, especially as the Trump administration pushes lower cost alternatives as a way to reduce the country’s drug bill.

“It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products,” said Leah Christl, director of the Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research. “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”


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