Mylan-Biocon Herceptin biosimilar gets first Indian approval

US generic major Mylan (NYSE: MYL) says that its partner, India-based biotechnology firm Biocon (BSE: 532523), has received approval for a Mylan-Biocon trastuzumab product from the Drug Controller General of India.

This is the first regulatory approval for a Mylan-Biocon developed biosimilar product. The product is a biosimilar to Roche's blockbuster cancer drug Herceptin (trastuzumab), indicated for the treatment of HER2 over-expressing breast cancer. Mylan intends to market its trastuzumab product under the trade name Hertraz.

Mylan chief executive Heather Bresch commented: "This regulatory achievement marks another Mylan first and underscores our commitment to, and confidence in, our biologic development program with Biocon and our belief that these products will become a global growth driver for Mylan over the long-term. We expect to launch our trastuzumab product in India early next year, marking our first launch of a biologic, and we look forward to bringing a high quality, affordable product to patients in India who need it. This launch also further strengthens our expanding commercial presence in India, as we enter the oncology and critical care segments."