Hospira submits BLA application to FDA for Retacrit, biosimilar for treatment of Anaemia

Hospira, Inc. has announced that it has submitted a Biologics License Application (BLA) to the FDA for Retacrit, a proposed biosimilar to Amgen's Epogen (epoetin alfa) and Janssen's Procrit (epoetin alfa). The biosimilar application was submitted on Dec. 16, 2014, under the new 351(k) approval pathway created by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

Comment: Biosimilars are biologic drugs that are highly similar to a reference biopharmaceutical product and demonstrate no clinically meaningful differences in terms of the safety, purity and potency of the product.They can be launched after expiry of the patent of the reference product. Biosimilars offer high-quality, lower-cost alternatives to reference biologics. The company has one of the largest biosimilar pipeline in the industry and currently is the only US-based drug maker with biosimilars in Europe, where Hospira has marketed Retacrit since early 2008. Hospira also markets a biosimilar version of Amgen's Neupogen (filgrastim) in Europe and Australia.