AVT03 is a proposed biosimilar to Amgen’s 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 Alvotech’s manufacturing facility in Reykjavik, Iceland.
Hyderabad-based Dr. Reddy’s Laboratories is a global pharmaceutical company. It offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC.
The company’s 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.