Trendlyne first wrote about Biocon-Mylan's trastuzumab R&D effort in December 2016, when Biocon and Mylan announced successful trials for its breast cancer drug, trastuzumab. Biocon-Mylan's biosimilar product will compete with Roche's branded trastuzumab product, Herceptin. Biocon has jumped in share price on the news.
While much is being made of the FDA approval Biocon has won for trastuzumab (the company is the first to launch the biosimilar), Roche is moving quickly with its more effective Perjeta drug - a trastuzumab+pertuzumab combination for the treatment of breast cancer, which would make treatment with trastuzumab alone an older, less effective option. The FDA has granted Roche a "Priority Review" for its application for this drug. The FDA is expected to make a decision on approval by 28 January 2018, which would allow Roche to hit the market quickly with this product, and make trastuzumab-only options such as Biocon-Mylan's biosimila much less attractive.