Nov. 27, 2019: U.S. Food and Drug Administration (FDA) approved Biocon and Mylan’s supplemental Biologics License Application (sBLA) for Pegfilgrastim Drug Substance to be manufactured at Biocon’s new Biologics manufacturing facility.
This additional approval will enable Biocon and Mylan to scale up capacity multi-fold and deal with the growing market opportunities in the U.S. and other global markets.
Pre-Approval Inspection conducted by U.S. FDA for new Drug Substance manufacturing facility from Sep 10 to Sep 19, 2019.
Continued dispersion of biosimilars will facilitate higher cost savings for the U.S. healthcare system leading to development of patient access to high quality affordable biologics.
Biocon Biologics with Mylan has commercialized three of its co-developed biosimilars in developed markets like U.S., Canada, EU and Australia.
Fulphila® was the first biosimilar Pegfilgrastim to be approved in the U.S.,it was one of the most successful biosimilar launches in the U.S. Biocon Biologics, by providing innovative affordable healthcare solutions going beyond the product is committed to serve the needs of patients, people and partners.
It aims to impact 2.6 million patient lives in FY 20 and pursue to position the company as a global leader.
https://www.biocon.com/biocon_press_release_20191127.asp
