Biocon Biologics Bengaluru facility gets 5 USFDA observations

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. 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. Read also: Biocon Biologics appoints Deepali Naair as Global Head - Brand & Corporate Communications