US FDA Approves the sBLA For Pegfilgrastim New Manufacturing Facility of Biocon.
With the acceptance of the extra facility, Biocon Biologics and Mylan is going to have the ability to tackle the growing demands of patients for biosimilar Pegfilgrastim in the US where introduction of the biosimilar has enlarged the overall market, increasing accessibility for patients in america, as well as in other global markets. Fulphila is also approved in other developed markets of Australia EU and Canada.
Dr. Christiane Hamacher, CEO, Biocon Biologics, stated:”This endorsement will help us meet international patient demands for Fulphila, a premium quality biosimilar Pegfilgrastim co-developed with Mylan and fabricated by Biocon Biologics. “Continued penetration of biosimilars will allow higher cost savings to the US healthcare system leading to growth of patient access to high quality affordable biologics. We’re dedicated to utilize our science, scale and expertise to alter the accessibility paradigm for individuals needing biosimilars like Pegfilgrastim across the globe,” she added.
Biocon Biologics, through its associate Mylan, has commercialized three of its co-developed biosimilars in developed markets like US, Canada, EU and Australia. It had been among the very successful biosimilar launches in the US.
Biocon Biologics, that homes Biocon’s biosimilars business, is committed to serve the needs of individuals, people and partners by providing innovative affordable healthcare solutions going beyond the item. It aims to impact 2.6 million individual lives in FY 20 and succeeds to position the company as an international leader.