Dr. Reddy's Laboratories' Swiss subsidiary received a Complete Response Letter (CRL) from the USFDA for its biosimilar AVT03 (denosumab). The CRL is related to USFDA observations during an inspection of Alvotech's manufacturing facility in Iceland, where AVT03 was developed. AVT03 is a proposed biosimilar to Amgen's Prolia and Xgeva. Dr. Reddy's is a global pharmaceutical company with a diverse product portfolio.