Hospira, Inc. (HSP), a provider of injectable drugs and infusion technologies, Monday announced the submission of a Biologics License Application or BLA to the U.S. Food and Drug Administration for Retacrit. The drug is a biomilar of Amgen's Epogen and Janssen's Procrit. Earlier in mid December, the company has submitted biosimilar application under 351(K).
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. Biosimilars offer high-quality, lower-cost alternatives to reference biologics.
For comments and feedback: editorial@rttnews.com