On December 31, 2025, Dr. Reddy’s Laboratories disclosed that its wholly owned Swiss subsidiary received a Complete Response Letter from the U.S. Food and Drug Administration for the Biologics License Application for AVT03 (denosumab), a proposed biosimilar to Prolia and Xgeva developed by Alvotech. The FDA’s response is tied to observations from a pre-license inspection of Alvotech’s manufacturing facility in Reykjavik, signaling that approval of this important biosimilar candidate for the U.S. market will be delayed until the inspection issues are resolved, potentially impacting the timing of Dr. Reddy’s entry into the denosumab biosimilar space and related revenue expectations.
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