Last week US Federal Court of Appeals decided against Amgen. The American company could not protect Epogen, the drug against anemia, from the Pfizer‘s biosimilar. However, failure at the Court of Appeal does not mean that Amgen will immediately face competition from a cheaper drug.
The appeals expert group concluded that its jurisdiction does not apply to the decision of the lower court, according to which, Amgen’s request for more detailed information about Pfizer’s product was rejected. The disagreement broke out since Amgen believes that the drug company Pfizer does not meet the requirements of the Biologics Price Competition and Innovation Act (BPCIA), as the company plans to bring to the market one more biosimilar.
Pfizer’s Hospira in 2014 filed an application for the registration of this biosimilar and sent a copy of the application to Amgen. Amgen replied that Hospira did not provide enough information because the details of the production process were not disclosed.
Pfizer challenged this claim, and the lower court took her side.
Even though most FDA expert council members voted to approve the biosimilar, in June the regulator sent to the company a complete response letter (CRL) due to site problems in McPherson, where manufacturing is planned. For Pfizer, the positive in this situation is that the regulator did not request additional information, as was the case with the rejection of the application for registration of the biosimilar in 2015.