USFDA accepts Biocon cancer drug biosimilar application

FDA decision likely in September; drug is similar to branded Trastuzumab, which treats breast cancer

India's largest biopharma firm Biocon Ltd and its US partner Mylan said the US Food and Drug Administration (USFDA) has accepted the biologics licence application for its biosimilar drug to treat breast cancers. An FDA would help the drug enter the lucrative US market.

The drug, a proposed biosimilar to branded trastuzumab, will be used to treat breast cancer. The companies expect a decision from FDA by September 3.

"This is Mylan and Biocon's first US regulatory submission through the 351(k) pathway and reinforces the strength of our collaboration to increase access to a broad portfolio of high-quality, affordable biosimilars worldwide," said