Biosimilars Regulatory Framework Must Evolve in Line with Emerging Scientific Evidence

Dr. Sundar Ramanan, Global Head of Regulatory Affairs, Biocon Biologics Dr. Sundar Ramanan, Vice President & Head, Global Regulatory Affairs, Biocon Biologics, presented on behalf of the Company at the public meeting for the reauthorization process for the Biosimilar User Fee Act (BsUFA III) program organized by the U.S. Food and Drug Administration (FDA) on … Continue reading Biosimilars Regulatory Framework Must Evolve in Line with Emerging Scientific Evidence

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