The FDA has accepted for review an application submitted by Mylan N.V. (“Mylan”) and Biocon Ltd. (“Biocon”) under the 351(k) pathway for MYL-1401K, a proposed biosimilar to Amgen’s Neulasta® (pegfilgrastim).  According to the announcement, the BSUFA date (FDA’s target goal) for a decision on the application is October 9, 2017.

The FDA has not

Dr. Leah Christl, the FDA’s Associate Director for Therapeutic Biologics, Office of New Drugs Therapeutic Biologics and Biosimilars Team at CDER, recently participated in a podcast on biosimilars.  During the discussion, she provided a “snapshot” of the biosimilar landscape at FDA.

According to Dr. Christl, as of February 1, 2017, there are 64 programs enrolled

Introduction

The Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated approval pathway for biological products shown to be “highly similar” to already FDA-approved biological products.  By permitting the sponsor of a biological product to rely on data submitted by the holder of an FDA-approved biological product, the BPCIA is somewhat similar in concept

On January 12, 2017, FDA released its long-awaited final guidance on naming of biologics and biosimilars, entitled “Nonproprietary Naming of Biological Products.”  According to FDA, the nonproprietary naming convention provided in the final guidance is intended to aid pharmacovigilance and to help prevent confusion and inadvertent substitution.

FDA’s newly-issued guidance covers the nonproprietary naming convention