Biocon Shares Slump 2% as USFDA Issues 5 Observations
Shares of Biocon Ltd fell 2% during the early trading hours on Thursday, 30 April, after the company announced that the US drug regulator had issued a Form 483 with five observations for its biosimilars site in Bengaluru.
Biocon stated that the US Food and Drug Administration issued a Form 483, following its pre-licence inspection of Biocon’s biosimilars site in Biocon Park, Bengaluru.
The inspection took place between 20 April and 29 April 2026, and included three biologics manufacturing units, five quality testing laboratories, and two warehouses.
Biocon stated that the observations are procedural and have nothing to do with data integrity or quality oversight. There were no repeat observations, according to the exchange filing.
Biocon stated that it will submit a complete corrective and preventative action (CAPA) plan within the specified time frame and is sure that all observations will be addressed fully and promptly.
Biocon announced last week that it has acquired approval from Health Canada for two denosumab biosimilars, Bosaya and Vevzuo, to treat osteoporosis and cancer-related bone disorders.
The approval was given on 3 April and includes Bosaya as a biosimilar to Prolia and Vevzuo as a biosimilar to Xgeva, both in regularly used dose forms.
At 10:31 am, the shares of Biocon were trading 1.31% lower at Rs 357.50 on NSE.
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