FDA issues complete response letter for Biocon's Insulin-R application

Shares of India’s largest biotech firm Biocon (BSE: 532523) slumped 2.4% to record a new 52-week low, after its subsidiary Biocon Biologics informed that the US Food and Drugs Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for its Insulin-R product.

The setback comes roughly a year after Biocon Biologics significantly expanded its biosimilar business with the acquisition of the biosimilars unit of Viatris (Nasdaq: VTRS) for $3.3 billion.

The US FDA's letter cites additional data required in the submission of the license application. It further states that there is an expectation of satisfactory implementation of a Corrective and Preventive Action Plan (CAPA) pertaining to the Pre-Approval Inspection (PAI) of the company's Bengaluru facilities in August last year, the official statement reported.