USFDA31 Dec 2025, 08:01 pm
Dr. Reddy's Subsidiary Receives CRL from USFDA for AVT03 BLA
AI Summary
Dr. Reddy's Laboratories SA, Switzerland, a wholly owned subsidiary of Dr. Reddy's Laboratories Ltd, has received a Complete Response Letter (CRL) from the United States Food and Drug Administration (USFDA) for its Biologics License Application (BLA) for AVT03, a proposed biosimilar candidate to Prolia® & Xgeva®, developed by Alvotech hf. The CRL is in response to observations from a pre-license inspection of Alvotech’s Reykjavik manufacturing facility.
Key Highlights
- Dr. Reddy's Laboratories SA, Switzerland, a subsidiary of Dr. Reddy's Laboratories Ltd, received a CRL from the USFDA
- The CRL is for the Biologics License Application (BLA) for AVT03, a proposed biosimilar candidate to Prolia® & Xgeva®
- AVT03 is developed by Alvotech hf
- The CRL is due to observations from a pre-license inspection of Alvotech’s Reykjavik manufacturing facility