Dr Reddy's Laboratories announced that its wholly owned subsidiary, Dr. Reddy's Laboratories SA, Switzerland, has received a Complete Response Letter (CRL) from the USFDA for its Biologics License Application (BLA) for AVT03 (denosumab).
AVT03 is a proposed biosimilar to Amgens Prolia and Xgeva and has been developed by Alvotech hf. According to the company, the CRL pertains to observations made by the US Food and Drug Administration (USFDA) during a pre-licence inspection of Alvotechs manufacturing facility in Reykjavik, Iceland.Hyderabad-based Dr. Reddys Laboratories is a global pharmaceutical company. It offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC.
The companys consolidated net profit jumped 7.3% to Rs 1,347.10 crore on a 9.8% increase in revenue from operations to Rs 8,804.90 crore in Q2 FY26 over Q2 FY25.
The counter slipped 1.66% to Rs 1,250 on the BSE.
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