Amgen loses appeal over Epogen biosimilar
- A federal court on Thursday dismissed Amgen Inc's appeal of a lower court order which had denied the biotech's request to compel Pfizer, Inc. disclose more information about its biosimilar copy of Amgen's anemia drug Epogen.
- The legal setback comes a little less than two months after the Food and Drug Administration unexpectedly rejected Pfizer's copycat biologic, handing Amgen a temporary reprieve from inbound competition to one of its principal drugs.
- Amgen had filed a motion to compel discovery from Pfizer's Hospira unit regarding two patents protecting Epogen, but the U.S. District Court for the Delaware shot that request down, leading to Amgen's subsequent appeal.
Hospira had already submitted its Epogen biosimilar to the FDA for approval and, in May 2017, secured the backing of an FDA advisory panel. So far, so good.
But in June, the FDA somewhat unexpectedly rejected the copycat biologic, issuing a second complete response letter — the first had been back in 2015 — and flagging previous warnings of manufacturing violations at Hospira's McPherson, Kansas manufacturing plant.
Pfizer has been working to bring that plant up to code since its acquisition of Hospira in 2015, but problems at the site continue to give the pharma giant headaches.
Amgen and Pfizer's tussle in court over the Epogen biosimilar is representative of the legal back-and-forth occurring throughout the industry as more biosimilars move towards market. These legal battles have been a hurdle to biosimilar drugmakers bringing the drugs to market, adding another layer to the already complex market.
Commercially, Epogen's sales are falling, down 12% year over year to $292 million in the second quarter this year. According to Amgen, this was driven primarily by declines in net selling price.
The drug's sales, which made up 5% of the company's total product sales in the second quarter, will likely take a further hit when an Epogen biosimilar does finally arrive on the U.S. market.
There are already a number of biosimilars of Epogen available in Europe and India including Pfizer/Hospira's epoetin alfa, which has been approved in the EU since 2008 as Retacrit. However, none have yet been approved or launched on the slower-developing U.S. biosimilars market.
- U.S. Court of Appeal Opinion of the court
- Big Molecule Watch Federal circuit dismisses Amgen's appeal and mandamus petition
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