‘Patient-first, Science Based Regulatory Approaches for Insulins’

Dr. Sundar Ramanan, VP, Global Regulatory Affairs, Biocon, Presented at the U.S. FDA Public Hearing on Increasing Insulins Access Biocon Ltd. was among a handful of biopharmaceutical companies that presented at the U.S. Food and Drug Administration’s (FDA) public hearing “The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and … Continue reading ‘Patient-first, Science Based Regulatory Approaches for Insulins’

Biocon’s Insulin Glargine Journey: Crossing a Key Milestone with EC Approval

As a credible, global insulins player, Biocon made sure-footed progress towards its mission of providing a high quality, affordable insulin analog for people with diabetes globally when the European Commission approved the biosimilar Insulin Glargine application submitted by its co-development partner Mylan. Biocon and Mylan are among the first few to receive approval for biosimilar … Continue reading Biocon’s Insulin Glargine Journey: Crossing a Key Milestone with EC Approval

Expanding Oncology Portfolio for the Benefit of Cancer Patients

We added another feather in our cap with the U.S. FDA approval of Fulphila™, biosimilar Pegfilgrastim co-developed with our partner Mylan. Fulphila™ is the first FDA-approved biosimilar Pegfilgrastim and the second biosimilar from Biocon and Mylan’s joint portfolio approved in the U.S. Pegfilgrastim is a long-lasting, pegylated form of recombinant granulocyte colony-stimulating factor that is … Continue reading Expanding Oncology Portfolio for the Benefit of Cancer Patients

Biocon’s Trastuzumab Journey: First biosimilar from India to be approved by U.S. FDA

December 2017 was a defining moment in our biosimilars journey when Biocon and partner Mylan became the first companies globally to receive U.S. Food and Drug Administration (FDA) approval for biosimilar Trastuzumab. Ogivri™ (trastuzumab-dkst) was the first biosimilar from Mylan and Biocon’s joint portfolio approved in the U.S., and it made us the first Indian … Continue reading Biocon’s Trastuzumab Journey: First biosimilar from India to be approved by U.S. FDA