Dr. Reddy's Laboratories Limited announced that in furtherance to intimation dated October 12, 2023, on the Pre-Approval Inspection (PAI) at Biologics manufacturing facility in Bachupally, Hyderabad, and announcement dated July 12, 2023, on the acceptance of the Biologics License Application (BLA) of proposed biosimilar rituximab candidate DRL_RI, they would like to inform that the United States Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) to BLA. The CRL is in reference to ongoing resolution of observations arising from the inspection of Biologics facility in October 2023, as well as certain aspects pertaining to the BLA. This has no impact on the development or manufacturing of any current commercial or pipeline product.

They will continue to work closely with the USFDA to address and resolve all concerns within stipulated timelines in order to make this biosimilar rituximab available to patients in the U.S. as soon as possible.