Drug Approval | September 30, 2024
USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia
The inspection concluded with the issuance of a form 483 with five observations
The inspection concluded with the issuance of a form 483 with five observations
The Notes shall not be offered or sold in India
These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity
Biocon Biologics earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
Renews GMP certifications for India and Malaysia sites
The approval of YESAFILI marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States
Both organisations enter into a long- term collaboration to expand patient access in India
This agreement paves the way for the introduction of YESAFILI into the Canadian market
The agreement licenses the company to launch in the United States, in February 2025, once approved by the U.S. FDA
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