Trastuzumab

Approved as a biosimilar to Herceptin®, bTrastuzumab was the first monoclonal antibody product which marked the entry of Biocon as a global biosimilars player. It took six years of rigorous development, from lab to commercial launch in India in 2014 (CANMab TM ), and was the world’s first biosimilar Trastuzumab. What makes the achievement even more significant is the fact that the approval took place at a time when global biosimilar regulatory guidelines wer still evolving. Biocon’s bTrastuzumab was also the first to receive approval from the U.S. FDA in 2017 and the only molecule in our portfolio to have undergone and received unanimous recommendation from the U.S. FDA’s Oncologic Drugs Advisory Committee, prior to approval as Ogivri®. This milestone further underscored the confidence of the regulators in Biocon’s science and product quality, safety and efficacy.