Biocon gets EIR from USFDA for small molecules API facility

Biocon Limited has received an Establishment Inspection Report (EIR) from US Food & Drug Administration (USFDA) for the post-approval and GMP inspection of its small molecules API Manufacturing Facility at 20 km, Biocon Campus, Bengaluru.

The said inspection was conducted between February 20 and February 26, 2020. The EIR has been closed with a ‘VAI’ classification for the observations. At the conclusion of the inspection last month, the agency had issued a form 483, with two observations, which were procedural in nature and are being addressed by the company.

Last week, the company had announced that it had won US court ruling that invalidated Sanofi patent on Insulin Glargine device, removing a key legal hurdle of commercialising Semglee co-developed with Mylan, in US. Additionally, USFDA had accepted Mylan’s biologics license application (BLA) for MYL-14020, a proposed biosimilar to Avastin (bevacizumab), for review under 351(k) pathway.

Biocon Limited is a leading biopharma company in India. Its domestic business has multiple divisions such as metabolics, oncology, nephrology, immunotherapy and comprehensive care. Along with partner Mylan, it has become first to get biosimilar Trastuzumab and Pegfilgrastim globally, approved in US in 2017 and 2018, respectively.

On Friday, the stock of Biocon opened at Rs 259.80. In the early morning trading session, it surged four per cent to Rs 262.55 from its previous close of Rs 252.55 on BSE.