Amgen lost a round in litigation in seeking to defend its product, Epogen (epoetin alfa), a drug to treat anemia associated with chronic renal failure and cancer chemotherapy, from biosimilar competition. A federal appeals court ruled that it does not have jurisdiction over a federal district court ruling that denied Amgen’s request for more information about a proposed biosimilar of epoetin alfa from Hospira, a subsidiary of Pfizer. Epogen is a top-selling product for Amgen with 2016 sales of $1.28 billion. 

The dispute involved disclosure requirements and related information-exchange requirements under the Biologics Price Competition and Innovation Act (BPCIA). Pfizer’s Hospira filed an application with the US Food and Drug Administration (FDA) in December 2014 seeking approval of a biosimilar of Epogen. Hospira provided a copy of its application to Amgen, however, Amgen claimed that Hospira did not separately provide information about the process used to manufacture the product. Specifically, Amgen said that Hospira had failed to fully disclose the specific composition of the cell-culture medium used in the manufacture of its proposed biosimilar. Hospira countered that the components Amgen had identified were commercially available raw materials and that it had provided sufficient information in its application.

Additionally, under requirements of the BPCIA, Amgen was required to provide to Hospira a list of patents in which Hospira’s proposed biosimilar may infringe. Amgen provided patents relating to the biological product and methods of producing the biological product rather than the specific cell-culture medium used during its manufacturing process, according to the court’s ruling. Amgen stated that without information regarding the cell-culture medium used by Hospira, it could not assess the reasonableness of asserting claims for infringement. Amgen then filed suit against Hospira on two patents, which did not include a cell-culture patent, but sought discovery on the composition of Hospira’s cell-culture medium. A lower court, a federal district court, denied Amgen’s motion, stating that the cell-culture information sought by Amgen was not relevant. Amgen appealed the district court’s interlocutory order, and Hospira sought to have the federal appeals court dismiss Amgen’s appeal for discovery for reason of lack of jurisdiction. The federal appeals court ruled that it did not have jurisdiction to rule on this matter. A previously scheduled trial on other patent-infringement issues is scheduled to proceed and begin on September 18, 2017, according to Amgen’s second-quarter 2017 filing with the US Securities and Exchange Commission.

Separately, Amgen received a delay in a proposed biosimilar for Epogen when in June 2017, Pfizer received a Complete Response Letter (CRL) from the FDA regarding its biologics license application for its proposed epoetin alfa biosimilar over manufacturing issues. In May 2017, the FDA Oncologic Drugs Advisory Committee (ODAC) voted to recommend Pfizer’s proposed biosimilar for approval.

The CRL relates to matters noted in a Warning Letter issued in February 2017 following a routine FDA inspection of the company’s facility in McPherson, Kansas in 2016. The issues noted in the Warning Letter do not relate specifically to the manufacture of epoetin alfa, noted Pfizer in a company statement. Pfizer submitted a corrective and preventative action plan to the FDA in March 2017 and said it has been working to address the items outlined in the Warning Letter. Pfizer further noted that it provides regular updates to the FDA on the status of its action plan and that it remains dedicated to addressing all of FDA’s concerns with the McPherson site.

Source: United States Court of Appeals for the Federal Circuit