Dr. Reddy’s Laboratories SA, Switzerland, a subsidiary of Dr. Reddy’s, has received a Complete Response Letter (CRL) from the USFDA for its Biologics License Application (BLA) for AVT03 (denosumab). This biosimilar candidate, developed by Alvotech hf, references Prolia® & Xgeva®. The CRL is based on observations from a pre-license inspection of Alvotech’s Reykjavik manufacturing facility.
USFDA Issues CRL for Denosumab Biosimilar
Dr. Reddy’s Laboratories SA, Switzerland, has been informed by the United States Food and Drug Administration (USFDA) that its Biologics License Application (BLA) for AVT03 (denosumab) has received a Complete Response Letter (CRL).
Details on the Biosimilar Candidate
AVT03, the proposed biosimilar candidate to Prolia® & Xgeva®, has been developed by Alvotech hf (“Alvotech”).
Manufacturing Facility Observations
The CRL is related to observations arising from a pre-license inspection of Alvotech’s Reykjavik manufacturing facility. No further details were provided in the announcement.
Source: BSE
