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")...