Dr. Reddy's Laboratories Limited has informed the Exchange regarding 'Disclosure under Regulation 30 of SEBI (LODR) Regulations, 2015'.
DRREDDY · price
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Dr. Reddy's wholly owned Swiss subsidiary has received a Complete Response Letter (CRL) from the USFDA for its Biologics License Application for AVT03 (denosumab), a proposed biosimilar of Prolia and Xgeva. The product is being developed by partner Alvotech hf. The CRL specifically cites observations from a pre-license inspection of Alvotech's manufacturing facility in Reykjavik, Iceland. A CRL means the application cannot be approved in its current form and the company will need to address the USFDA's concerns before re-submission. The issues flagged are related to the partner's manufacturing site rather than Dr. Reddy's own facilities.
Negative for the stock in the near term as it pushes back the potential US launch of the biosimilar and raises questions about the partner facility. However, the issues are at Alvotech's plant (not Dr. Reddy's) and CRLs are often addressable, so the long-term impact depends on how quickly the observations are resolved.