US court denies Amgen appeal over Pfizer biosimilar

A US federal court has rejected Amgen’s appeal in a patent infringement case related to Pfizer’s biosimilar version of protein-based anaemia drug Epogen (epoetin alfa). Amgen was trying to overturn a lower court decision denying its request to force Pfizer to turn over additional details about its rival product, which would assist Amgen’s patent defence.

In June, the US Food and Drug Administration denied Pfizer final approval for its epoetin alfa biosimilar, based on manufacturing deficiencies at its Hospira unit. This had given Amgen a temporary reprieve from competition, which it is aiming to extend through patent litigation.

In response, Amgen said the court dismissed its appeal for lack of jurisdiction. ‘We remain confident in our patents and look forward to presenting our arguments during the tria,’ the company stated.