With a federal appeals decision handed down this week, Amgen has come up short in a legal attempt to defend blockbuster anemia med Epogen from a Pfizer biosim. However, the company’s loss in appeals doesn’t mean its drug will face cheap competition right away.
An appeals panel ruled that it doesn’t have jurisdiction over a lower court’s order denying Amgen’s request for more info about Pfizer’s product. The dispute stems from whether Pfizer met requirements of the Biologics Price Competition and Innovation Act (BPCIA) as it seeks to bring another biosim to market.
Back in 2014, Pfizer’s Hospira filed a biosim application for the drug, according to the Thursday opinion, and sent a copy of that application to Amgen. Amgen responded that Hospira didn’t provide enough information because the biosim maker didn’t disclose manufacturing details.
Pfizer disputed that argument and ultimately a lower court took its side, denying Amgen’s motion to compel discovery.
"The Federal Circuit issued a decision on our appeal of a discovery issue dismissing the appeal for lack of jurisdiction," an Amgen spokesperson said in a statement. "We remain confident in our patents and look forward to presenting our arguments when the trial begins on September 18."
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About $1.28 billion in revenue is at stake, but even with the loss in appeals, California-based Amgen is safe from Epogen biosim competition for now. That is because Pfizer’s candidate stumbled at the FDA in June. Despite an earlier 14-1 panel vote in favor of approval, the agency issued a complete response letter related to issues at a plant in McPherson, Kansas, that will produce the drug. On the bright side for Pfizer, the FDA didn’t ask for more data to support approval as it did when it rejected the proposed biosim back in 2015.
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Thanks to its $15 billion Hospira buy, Pfizer is a leading player in biosims. The drugmaker has already launched a biosimilar to Johnson & Johnson’s Remicade and has late-stage candidates targeting AbbVie’s Humira plus Roche’s Avastin, Rituxan and Herceptin, according to its website.
The Supreme Court recently sided with biosim developers in its interpretation of the BPCIA, saying they don’t have to wait until FDA approval to provide 180-day marketing notice. Further, the court ruled that “patent dance” violations of the law aren’t enforceable by federal injunction.
Editor's note: This story was updated with a statement from Amgen.