Mylan and partner Biocon have received approval in India for their biosimilar version of Roche’s breast cancer blockbuster Herceptin.
The Drug Controller General of India has granted the first regulatory green light for a Mylan/Biocon-developed biosimilar and the former will launch its copy of Herceptin (trastuzumab), under the tradename Hertraz, early next year.
Trastuzumab is one of five biologics the partners are working on and Mylan has exclusive commercialisation rights for the former. Chief executive Heather Bresch said that “this regulatory achievement marks another Mylan first and underscores our commitment to, and confidence in, our biologic development programme with Biocon”.
She added that “we look forward to bringing a high quality, affordable product to patients in India who need it”, noting that “this launch also further strengthens our expanding commercial presence in India, as we enter the oncology and critical care segments”.
Earlier this year, the Indian government said it was looking at putting in place a compulsory license on Herceptin and Roche is not defending its patents on the drug there. Herceptin had sales in India of about $21 million in 2012.
