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
Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations
The approval further adds to Biocon’s portfolio of complex drug products
Biocon Biologics earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025
This strong performance was primarily on account of a one-time gain from the strategic collaboration between Biocon Biologics and Eris Lifesciences.
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
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