Company Statements - Biocon

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COMPANY STATEMENTS

2023

Biocon Pharma Limited’s facility at Bengaluru Concludes USFDA Surveillance and Inspection, With Zero Observations

Jun 3, 2023

Biocon’s API facility at Hyderabad Concludes USFDA Inspection, with Zero Observations

May 20, 2023

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

Apr 28, 2023

USFDA issues a CRL for the Biologics License Application for Bevacizumab

Feb 12, 2023

USFDA issues a CRL for the Biologics License Application for Insulin-R

Jan 7, 2023

2022

Biocon Limited receives the final inspection report from EDQM

Dec 22, 2022

Biocon Biologics Insulins Facility in Malaysia Receives EU GMP Certification

Oct 21, 2022

Biocon Biologics Consolidated Statement on USFDA Inspections

Aug 31, 2022

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

Aug 25, 2022

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

Jul 5, 2022

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

Jun 21, 2022

Biocon Biologics Denies Bribery Allegations

Jun 21, 2022

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

Mar 3, 2022

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

Jan 7, 2022

2021

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

Sep 25, 2021

Biocon Limited enters into a settlement agreement with Celgene Corp.

Sep 8, 2021

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

Apr 28, 2021

Biocon Biologics and Viatris Receive European Commission Approval for Biosimilar Bevacizumab

Apr 26, 2021

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

Apr 12, 2021

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

Feb 12, 2021

2020

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

Dec 25, 2020

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

Dec 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

Apr 16, 2020

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

Apr 1, 2020

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

Mar 20, 2020

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

Feb 27, 2020

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

Feb 22, 2020

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

Jan 27, 2020

Biocon’s Oral Solid Dosage Manufacturing Facility Completes Pre-Approval U.S. FDA lnspection with Zero Observations

Jan 20, 2020

2019

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

Sep 20, 2019

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

Aug 31, 2019

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

Aug 31, 2019

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

Jul 8, 2019

Biocon Biologics Facilities in Bengaluru Receive EU GMP Certification

Jun 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

Mar 6, 2019

Biocon Facilities complete Pre Approval U.S. FDA lnspection

Feb 18, 2019

2018

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

Dec 19, 2018

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

Dec 17, 2018

Biosimilar Pegfilgrastim Co-Developed by Biocon Receives Approval in EU

Nov 30, 2018

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

Nov 12, 2018

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

Sep 22, 2018

Biocon’s Sterile Drug Product facility Receives EU GMP Certification

Jul 4, 2018

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

Jun 23, 2018

Biocon Update on Insulin Glargine

Jun 2, 2018

Biocon Regulatory Audit Update

May 2, 2018

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

Apr 11, 2018

Update on Company Statement on US-FDA Inspection at Biocon Malaysia

Mar 13, 2018

Company Statement on US-FDA Inspection at Biocon Malaysia

Feb 21, 2018

2017

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

Dec 13, 2017

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

Nov 20, 2017

Resubmission of Biosimilar Trastuzumab and Pegfilgrastim Dossiers with EMA

Nov 7, 2017

US FDA Issues Complete Response Letter for Proposed Biosimilar Pegfilgrastim

Oct 10, 2017

No Separate Audit or Observations by Health Canada

Oct 6, 2017

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

Sep 18, 2017

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

Sep 7, 2017

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

Aug 30, 2017

Status of EMA Dossiers

Aug 16, 2017

USFDA visit in May/June 2017

Aug 3, 2017

Biocon Receives GMP approval for Biologics Drug Substance facilities from French Regulator; Drug Product facility to be re-inspected

Jul 9, 2017

Media Reports on USFDA 483s

May 5, 2017

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