Pfizer announced last week that the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended its proposed biosimilar to Amgen’s Epogen®/Procrit® for approval across all indications after a public meeting held on May 25, 2017.  The meeting materials are available from the FDA’s website here.

The history of this application is interesting.  The original biologics application (BLA 125545) was submitted by Hospira in December 2014 and was subsequently acquired by Pfizer when it purchased Hospira in 2015.  The initial BSUFA date (FDA’s target goal for action) was in November 2015.  The application was rejected after the FDA’s first review, and Pfizer publicly stated in October 2015 that it received a complete response letter from FDA that would delay the anticipated release of the product.  At that time, Pfizer indicated “that it was working closely with the agency to address the concerns of the letter” and expected to resubmit the application.  Since then, few details have been available on the status of the application, although under current performance goals, the FDA aims to take action within approximately six months of resubmission of an application.

Epoetin alfa is a human erythropoietin that stimulates the production of red blood cells (erythropoiesis). Epoetin alfa is produced in cell culture using recombinant DNA technology. The proposed indications for Pfizer’s proposed biosimilar include: (1) the treatment of anemia due to chronic kidney disease; (2) the treatment of anemia due to zidovudine in HIV-infected patients; (3) the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppresive chemotherapy; and (4) reducing the need for allogeneic RBC transfusions among patients with perioperative hemoglobin who are at high risk for perioperative blood loss from elective, noncardiac, and nonvascular surgery.

Hospira’s Retacrit® was approved in the EU in 2007, and according to Pfizer’s announcement, this product is the first biosimilar erythropoiesis-stimulating agent (“ESA”) recommended for approval by an FDA Advisory Committee.  The announcement notes that the FDA will take the ODAC’s recommendation into consideration before taking final action on the application, and indicates that once approved, the product will be commercialized pursuant to an agreement between Pfizer and Vifor Pharma, Inc.

Amgen filed a Complaint for patent infringement under the BPCIA against Hospira regarding this product in the United States District Court for the District of Delaware in September 2015.  The Complaint alleges infringement of two patents (U.S. Patent Nos. 5,856,298 and 5,756,349) and contains separate claims for alleged violations of sections (l)(2)(A) and (l)(8) of the BPCIA.  Stay tuned for an in-depth discussion of the erythropoietin litigation, coming soon in the Litigation Spotlight series.