Company Statements Archives - Biocon Biologics

Leaving the Biocon Biologics Corporate Website

You are now leaving the Biocon Biologics Corporate website for a Biocon Biologics U.S. Corporate microsite that is solely responsible for its content, including its compliance with guidelines applicable in certain geographies. Links to Biocon Biologics affiliate sites are provided as a resource to our visitors and may not be governed by the same regulatory requirements applicable to this site and unaffiliated third party sites are subject to their own terms and data protection notices and practices. Moreover, if their third party site is subject to other country laws, regulatory requirements, data protection requirements or medical practices may differ between countries and the information provided therein may not be suitable for use in your country.

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Leaving the Biocon Biologics Corporate Website

You are now leaving the Biocon Biologics Corporate website for a Biocon Biologics EU Corporate microsite that is solely responsible for its content, including its compliance with guidelines applicable in certain geographies. Links to Biocon Biologics affiliate sites are provided as a resource to our visitors and may not be governed by the same regulatory requirements applicable to this site and unaffiliated third party sites are subject to their own terms and data protection notices and practices. Moreover, if their third party site is subject to other country laws, regulatory requirements, data protection requirements or medical practices may differ between countries and the information provided therein may not be suitable for use in your country.

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Leaving the Biocon Biologics site

You are now leaving the Biocon Biologics page for a Biocon Biologics affiliate site or third party site that is solely responsible for its content, including its compliance with guidelines applicable in certain geographies. Links to Biocon Biologics affiliate sites and third party sites are provided as a resource to our visitors and may not be governed by the same regulatory requirements applicable to this site and unaffiliated third party sites are subject to their own terms and data protection notices and practices. Moreover, if their third party site is subject to other country laws, regulatory requirements, data protection requirements or medical practices may differ between countries and the information provided therein may not be suitable for use in your country.

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Company Statements

U.S. FDA Classifies Biocon Biologics Site in Johor Bahru, Malaysia as Voluntary Action Indicated (VAI)

Japan Health Authority (PMDA) Approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J’s Stelara®

EMA’s CHMP recommends approval of Biocon Biologics’ YESINTEK®, biosimilar to J&J’s Stelara®

U.S. FDA Approves Biocon Biologics’ YESINTEK™, Bmab 1200 biosimilar to J&J’s Stelara® (Ustekinumab)

USFDA Classifies Biocon Biologics’ Biocon Park Site in Bengaluru, India as Voluntary Action Initiated (VAI)

Biocon Biologics’ Drug Substance Facility in Bengaluru Classified as Voluntary Action Indicated (VAI)

US FDA Completes Inspection at Biocon Biologics’ Insulins Facility at Johor Bahru, Malaysia

US FDA Completes Inspection at Biocon Biologics’ Facilities at Biocon Park, Bengaluru, India

EMA Approves Biocon Biologics’ New mAbs Facility in India and Renews GMP Certifications for India and Malaysia Sites

Biocon Biologics Secures Canada Market Entry Date for YESAFILI®, a Proposed Biosimilar to EYLEA®

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