USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent

The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer

USFDA inspection at Biocon Biologics' manufacturing facility in Johor, Malaysia

Dr Reddy's Bachupally biologics facility gets USFDA Form 483 with 9 observations

The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally

Biocon Biologics gets complete response letter from USFDA for Biosimilar Insulin Aspart

The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022

Biocon Biologics receives European Commission approval for biosimilar of Aflibercept ‘Yesafili’

The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway

Biocon Biologics completes integration of Viatris Biosimilars’ business in North America

Biocon Biologics recently acquired the global biosimilars business of its long-term partner Viatris

Biocon Biologics announces leadership appointments

USFDA accepts biologics license application for GC Biopharma's GC5107B

Biocon Biologics gets EMA’s positive opinion for an ophthalmology product

USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia

The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories