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News
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Company Statements
COMPANY STATEMENTS
2023
2022
2021
2020
2019
2018
2017
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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