Biocon Biologics Bengaluru facility gets 5 USFDA observations

Ruchika Sharma

Biocon Biologics Bengaluru facility gets 5 USFDA observations

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-09-05T11:21:12+05:30 | Updated On 5 Sept 2025 11:21 AM IST

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Bengaluru: Biocon has announced that the U.S. Food and Drug Administration (FDA) has concluded a routine cGMP inspection with five observations at Biocon Biologics' Drug Substance facility at Biocon Campus in Bengaluru, India.

The inspection was held between August 26, 2025, and September 3, 2025, covering drug substance manufacturing units, analytical QC laboratories, microbiology laboratories, and warehouses.

"At the conclusion of the inspection, the U.S. FDA issued a Form 483 with five observations," Biocon stated.

"These observations are procedural in nature and do not pertain to data integrity, systemic non-compliance, or quality oversight. Biocon Biologics will submit a comprehensive Corrective and Preventive Action (CAPA) plan within the stipulated timeline and is confident in its ability to address all observations expeditiously," the Company Spokesperson said in a statement.

"The company does not anticipate any impact on supply of its commercial products. Biocon Biologics remains committed to upholding the highest standards of Quality and Compliance, and working collaboratively with global regulatory agencies to ensure the safety, efficacy, and reliability of its products."

In July, Biocon Biologics Ltd launched Nepexto, a biosimilar to the reference product Enbrel (Etanercept), in Australia. Etanercept is a fusion-protein that inhibits tumor necrosis factor (TNF) and is used in the treatment of autoimmune diseases like rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

Read also: Biocon Pharma bags tentative USFDA nod for diabetes medicine Sitagliptin

Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated, global biosimilars company. Biocon Biologics has commercialized 10 biosimilars from its portfolio which are addressing the patients’ needs in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, bone health and other noncommunicable diseases.

bioconbiocon biologicsUSFDAUSFDA inspection

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751