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
In Conversation with Dr. Arun Chandavarkar, CEO & Jt. MD, on Biocon-Sandoz collaboration for Next Generation Biosimilars
CEO Speaks: On the major milestone for Biocon-Sandoz and how this collaboration will enable Biocon to address the next wave of Global Biosimilar Opportunities!
‘KRABEVA®’s Unique ‘Qual-Check’ Mechanism Ensures Patients Get a Quality-Ascertained Product’: Suresh Subramanian
Mr. Suresh Subramanian, Senior Vice President & Head Branded Formulations, Biocon shares his views on how KRABEVA® can make a significant impact in the biosimilars space.
‘Stand-out’ Quarter for Biocon’s Biologics Business
Biocon reported strong Q2FY17 results. Small Molecules, Biologics and Research Services businesses showed strong growth while it was a stand-out quarter for the Biologics business.
Realizing the Promise of Biosimilars in 2020
Part 2 – The potential financial benefits and better health outcomes from biosimilars use could spur their uptake in health systems globally.
Access and Affordability: Impact of Biosimilars
Part 1 – Biosimilars can provide cost-effective, high quality alternatives to expensive reference biologics, thus improving access and expanding the patient base.
A Blog by Biocon 