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Results For "Biocon-Biologics"

74 News Found

Biocon Biologics gets complete response letter from USFDA for Biosimilar Insulin Aspart
Drug Approval | October 09, 2023

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’
Drug Approval | September 21, 2023

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
News | September 07, 2023

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


USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia
Drug Approval | July 24, 2023

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


Biocon Biologics expands footprint in emerging markets
News | July 05, 2023

Biocon Biologics expands footprint in emerging markets

Takes over the commercialization of Biosimilars Business from Viatris in 70+ countries


Biocon Biologics' Hulio Biosimilar to Humira now available in the US
News | July 04, 2023

Biocon Biologics' Hulio Biosimilar to Humira now available in the US

The launch of HULIO in the United States is an important milestone for Biocon Biologics


Biocon Biologics' new mAbs facility receives EU GMP Certification for bBevacizumab
News | April 29, 2023

Biocon Biologics' new mAbs facility receives EU GMP Certification for bBevacizumab

This approval reflects Biocon Biologics' compliance with the highest international regulatory standards