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
Diabetes is a global epidemic and the number of people with diabetes globally is growing at an alarming rate. An estimated 463 million adults (20-79 years), or about 1 in 11 adults worldwide, are living with diabetes across the world in 2019; by 2045 this will rise to 700 million1. Globally, the number of people … Continue reading Early Insulinization Can be Key to Effective Diabetes Management
Diabetes Mellitus is a major health issue with nearly half a billion people living with this ailment globally. Diabetes is a serious, chronic or long-term condition that occurs when there are elevated levels of glucose in a person’s blood because their body cannot produce any or enough of the hormone insulin, or cannot effectively use … Continue reading A Disease of Halves: Why better patient adherence to treatment is important to manage diabetes?
Kiran Mazumdar Shaw speaks at the UNAIDS Health Innovation Exchange Meeting on the sidelines of United Nations General Assembly, held in New York on 25th September 2019. Your Excellencies, Distinguished Ladies and Gentlemen, We have just witnessed the first UN High Level meeting on Universal Health Care on Monday. Governments have a collective moral responsibility … Continue reading Kiran Mazumdar-Shaw Promises to Enable Universal Access to rh-Insulin by Reducing Prices to Less than 10 US cents/Day for LMICs
India and the U.S. are witnessing a deepening of ties with a convergence of views on many issues. India is rapidly emerging as a preferred economic and technology partner for the US. India IT and pharma companies have made significant investments and have created jobs in the US. These investments signal a growing economic interdependence … Continue reading US-India Leaders Summit: Paving the Way for Affordable Diabetes & Cancer Care in the US
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’
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
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
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
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!