Hyderabad, Aug. 1 -- Dr. Reddy's Laboratories on Saturday announced that the US Food and Drug Administration (USFDA) has approved its rituximab biosimilar, a biosimilar to Rituxan (rituximab), for the US market.
In a release, Hyderabad based pharma giant said the approval strengthens its global biosimilars portfolio and marks a significant step in expanding its biosimilars business in the United States.
According to Dr. Reddy's, the biosimilar was developed, manufactured and submitted for approval by the company.
The approval follows a successful Pre-License Inspection (PLI) by the USFDA at its biologics manufacturing facility in Bachupally, Hyderabad.
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