Company Statements

2025

Biocon Biologics Receives MHRA, UK Approval for YESINTEK®, Biosimilar Ustekinumab

May 25, 2025

Malaysian MoH Awards Insulins Supply Contract Extension to Biocon Biologics

May 22, 2025

Biocon Biologics and Yoshindo Expand Access to Ustekinumab Biosimilar in Japan

May 21, 2025

Biocon Biologics Receives Positive CHMP Opinions for Biosimilar Denosumab in Europe

April 26, 2025

European Commission Approves Biocon Biologics’ Ustekinumab Biosimilar

February 18, 2025

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

January 12, 2025

2024

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

January 7, 2025

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

December 15, 2024

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

December 1, 2024

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

November 10, 2024

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

October 30, 2024

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

September 28, 2024

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

July 27, 2024

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

June 24, 2024

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

March 4, 2024

Company Statement on rh-Insulin for Veterinary use

February 29, 2024

2023

Company Statement on Aflibercept

December 29, 2023

Biocon Biologics Receives MHRA, UK Approval for YESAFILI®, Biosimilar Aflibercept

November 13, 2023

Update on U.S. FDA Inspection at Biocon Biologics’ Manufacturing Facility in Johor, Malaysia

October 18, 2023

Biocon Biologics Receives Complete Response Letter from US FDA for Biosimilar Insulin Aspart

October 7, 2023

Biocon Biologics Receives European Commission Approval for YESAFILI®, Biosimilar Aflibercept

September 20, 2023

U.S. FDA Completes Two cGMP Inspections at Biocon Biologics Insulins Facility in Malaysia

July 21, 2023

Biocon Biologics’ New mAbs Facility Receives EU GMP Certification for bBevacizumab

April 28, 2023

2023

Biocon Biologics Consolidated Statement on USFDA Inspections

August 31, 2022

Biocon Statement on Parts of the Charge Sheet Leaked to a Media Outlet

August 25, 2022

Biocon Biologics Receives EU GMP Certification for Its New Biologics Manufacturing Facility in Bengaluru

July 5, 2022

Biocon Biologics issues a statement in response to the media reports related to bribery allegations

June 21, 2022

Biocon Biologics Denies Bribery Allegations

June 21, 2022

HPRA Completes Audit of Biocon Biologics New mAbs Drug Substance Facility in Bengaluru

March 3, 2022

The USFDA issues a complete response letter for the Biologics License Application (BLA) for insulin Aspart

January 7, 2022

2021

Biocon Biologics Insulin Manufacturing Facility in Malaysia Completes U.S. FDA (PAI) Inspection

September 25, 2021

Biocon Limited enters into a settlement agreement with Celgene Corp.

September 8, 2021

Kiran Mazumdar-Shaw Joins Board of Trustees of Memorial Sloan Kettering Cancer Center, U.S.

April 28, 2021

Biocon Biologics and Viatris Receive European Commission Approval for Biosimilar Bevacizumab

April 26, 2021

Biocon Pharma Limited, a wholly owned subsidiary of Biocon Limited, receives GMP compliance certificate from MHRA, UK

April 12, 2021

Biocon Biologics and Viatris Receive European Commission Approval for Kixelle, Biosimilar Insulin Aspart

February 12, 2021

2020

Biocon Biologics Statement on the Status of Bevacizumab FDA Action Date in Dec 2020

December 25, 2020

Biocon Biologics and Mylan Receive CHMP Recommendation for Approval of Biosimilar Insulin Aspart

December 14, 2020

Biocon Biologics Drug Substance Facilities in Bengaluru Receive EU GMP Certification

May 12, 2020

Biocon Receives EIR for Small Molecules API Manufacturing Facility for Pre -Approval and GMP U.S. FDA Inspection

May 8, 2020

Biocon Biologics Receives EIR from U.S. FDA for Two Manufacturing Facilities, Inspection Stands Closed

April 16, 2020

Biocon’s Insulin Manufacturing Facility in Malaysia Receives EIR from U.S. FDA with Voluntary Action Indicated (VAI) Classification, Inspection Stands Closed

April 1, 2020

Biocon Receives EIR for Small Molecules API Manufacturing Facility for Post – Approval and GMP U.S. FDA Inspection

March 20, 2020

Biocon’s Small Molecules API Manufacturing Facility Completes Post-Approval and GMP U.S. FDA Inspection

February 27, 2020

Biocon’s Insulin Manufacturing Facility in Malaysia Completes U.S. FDA (PAI) Inspection

February 22, 2020

Biocon’s Small Molecules API Manufacturing Facility Completes Pre-Approval and GMP U.S. FDA inspection

January 27, 2020

2019

U.S. FDA Completes Pre-Approval Inspection of Two New Biocon Biologics Facilities in Bengaluru

September 20, 2019

U.S. FDA Issues Complete Response Letter for New Drug Application for Insulin Glargine; Commercialization Plans Remain Unchanged

August 31, 2019

U.S. FDA completes surveillance (routine) cGMP inspection of one of our Biologics Drug Product facilities in Bengaluru

August 31, 2019

Pre-Approval U.S. FDA Inspection Conducted at Biocon’s Insulins Facilities in Malaysia

July 8, 2019

Biocon Biologics Facilities in Bengaluru Receive EU GMP Certification

June 14, 2019

Biocon Retains Economic Interest in Global Commercialization of Hulio®, (biosimilar Adalimumab) in-licensed by Mylan

May 7, 2019

Biocon Facility Completes Pre Approval U.S. FDA Inspection

March 6, 2019

Biocon Facilities complete Pre Approval U.S. FDA lnspection

February 18, 2019

2018

Biosimilar Trastuzumab Co-Developed by Biocon Receives Approval in the EU

December 19, 2018

Biocon’s APIs Manufacturing Facility in Telangana Completes U.S. FDA Inspection with No 483 Observations

December 17, 2018

Biosimilar Pegfilgrastim Co-Developed by Biocon Receives Approval in EU

November 30, 2018

Biocon’s Generic Formulations Facility in Bengaluru completes U.S. FDA Inspection with No 483 observations

November 12, 2018

Biocon’s Drug Substance Facility in Bangalore completes U.S. FDA Inspection with No observations

September 22, 2018

Biocon’s Sterile Drug Product facility Receives EU GMP Certification

July 4, 2018

Biocon’s Sterile Drug Product facility Receives EIR from U.S. FDA

June 23, 2018

Biocon Update on Insulin Glargine

June 2, 2018

Biocon Regulatory Audit Update

May 2, 2018

Mylan and Biocon seek to accelerate introduction of Adalimumab biosimilar in EU

April 11, 2018

2017

Biocon´s Clarification post media reports on “Biocon on the FDA list for not paying facility fee”

December 13, 2017

Biocon’s Drug product Facility Receives EIR with VAI status, Inspection Closed

November 20, 2017

Resubmission of Biosimilar Trastuzumab and Pegfilgrastim Dossiers with EMA

November 7, 2017

US FDA Issues Complete Response Letter for Proposed Biosimilar Pegfilgrastim

October 10, 2017

No Separate Audit or Observations by Health Canada

October 6, 2017

Biocon’s Facility in Vishakhapatnam completes US FDA Inspection with no observations

September 18, 2017

Biocon’s Insulins facility in Malaysia Receives EU GMP Compliance Certificate

September 7, 2017

USFDA Target Action Date for Trastuzumab reset to December 3, 2017

August 30, 2017

Status of EMA Dossiers

August 16, 2017

USFDA visit in May/June 2017

August 3, 2017

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