FDA Accepts Samsung Bioepis’ aBLA for Herceptin® Biosimilar

Yesterday, Samsung Bioepis announced that the FDA has accepted for review the company’s BLA under the 351(k) pathway for SB3, a biosimilar candidate referencing Genentech’s Herceptin® (trastuzumab).  The press release states that this is Samsung Bioepis’ first submission for FDA-approval of an oncology biosimilar candidate.  According to the press release, the biosimilar, if approved, will be commercialized in the United States by Merck & Co.

The acceptance of Samsung Bioepis’ application marks at least the fifth time the FDA has accepted for review an aBLA for a biosimilar of Herceptin, following prior acceptances this year of aBLAs submitted by Mylan, Pfizer, Celltrion, and Amgen.  The FDA approved Mylan’s biosimilar, Ogiviri™ (trastuzumab-dkst), earlier this month.