Dr. Reddy's Switzerland Receives FDA Complete Response Letter For AVT03 Denosumab Biosimilar BLA Following Manufacturing Inspection Findings

Disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements)
Regulations, 2015
This is to inform you that Dr. Reddy's Laboratories SA, Switzerland, wholly owned subsidiary of the
Company ("Dr. Reddy's Swiss") has received a Complete Response Letter (CRL) from the United States
Food and Drug Administration (USFDA) for its Biologics License Application (BLA) for AVT03
(denosumab), a proposed biosimilar candidate to Prolia® & Xgeva®, developed by Alvotech hf
("Alvotech"). The CRL refers to the observations from a pre-license inspection of Alvotech's Reykjavik
manufacturing facility.