FDA extends review of Samsung Bioepis’ trastuzumab biosimilar

A Samsung Bioepis Co. Ltd. spokesperson told BioCentury that FDA extended by three months its review of a BLA for SB3, a biosimilar of cancer drug Herceptin trastuzumab from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit. The company did not disclose details regarding the delay.

FDA accepted the BLA in December 2017, and the company now expects a decision in January. The biosimilar is approved in the EU as Ontruzant (see “EMA Approves First Herceptin Biosimilar”).

Trastuzumab is a humanized mAb against HER2.

The setback is the second this month for a biosimilar in the U.S. The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) said Nov. 2 that it would no longer seek U.S.approval of GP2013, its biosimilar of cancer and autoimmune drug Rituxan/MabThera rituximab from Roche (see “Sandoz Gives Up on Rituxan Biosimilar in U.S.”).

Samsung Bioepis is a JV between Biogen Inc. (NASDAQ:BIIB) and Samsung BioLogics Co. Ltd. (KOSDAQ:20740).

https://www.marketscreener.com/BIOGEN-4853/news/FDA-extends-review-of-Samsung-Bioepis-trastuzumab-biosimilar-27580503/