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.
2008-13
Early process development of biosimilar Trastuzumab began with antibody cloning and cell line engineering, followed by process development and analytical characterization. This phase established the foundation for clinical evaluation. Late-stage development included a multi- centric Phase III clinical trial in India to assess safety and efficacy. These efforts culminated in successful regulatory filing in India.
2013
After successful regulatory submission to the Drug Controller General of India, Biocon becomes the first company to receive approval for a biosimilar Trastuzumab anywhere in the world. Global clinical trials for biosimilar Trastuzumab begin with the HERITAGE study.
2014
Biosimilar Trastuzumab is launched in India as CANMAb®.
2016
BLA for biosimilar Trastuzumab is submitted to U.S. F.D.A.
2017
Ogivri® becomes the first biosimilar Trastuzumab to be approved by U.S. F.D.A., making Biocon the first Indian company to have an approval for a biosimilar in the U.S.
2018
Biocon receives regulatory approvals for biosimilar Trastuzumab in Europe, Brazil and Turkey.
2019
Biocon and Mylan launch Ogivri®, a biosimilar to Herceptin®, in the U.S.
Ogivri® becomes the first biosimilar Trastuzumab to be approved in Canada.
Ogivri® is the first biosimilar Trastuzumab to be approved and launched in Australia.
2021
Biosimilar Trastuzumab receives WHO prequalification, enabling access to 46 low- and middle-income countries through global health programs.
2024
Biocon Biologics announces a five-year exclusive partnership with Sandoz AG to promote, sell, and distribute Ogivri® in Australia.
Related Links
Our Bevacizumab biosimilar journey reflects our commitment to advancing oncology care by ensuring global access to this critical anti-angiogenic therapy....
The journey of our Pegfilgrastim biosimilar reflects our commitment to improving supportive cancer care. Designed to enhance white blood cell...
