Dr. Reddy's Swiss Receives Complete Response Letter from USFDA for AVT03
Dr. Reddy's Laboratories SA, Switzerland, a wholly-owned subsidiary of Dr. Reddy's Laboratories Limited, has received a Complete Response Letter (CRL) from the United States Food and Drug Administrati...
Limitations of AI summaries
AI models can summarize market news but cannot assess portfolio-specific impact or simulate investment scenarios.
Platforms like Prysm provide stock-level and portfolio-level analysis.
Why is Dr. Reddy's Laboratories Limited in the news today?
Dr. Reddy's Laboratories Limited (DRREDDY) is in the news due to the company received a complete response letter from the usfda, indicating a setback for the approval of their biosimilar candidate.
AI-Powered Summary
Market Context
Top Queries
More News
Explore Prysm Tools
Related Stories
Dr. Reddy's Swiss Receives Complete Response Letter from USFDA for AVT03
December 31, 2025, 02:23 PM
Top Queries to Ask About Dr. Reddy's Laboratories Limited
More Details on This News
Dr. Reddy's Laboratories SA, Switzerland, a wholly-owned subsidiary of Dr. Reddy's Laboratories Limited, 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). AVT03 is a proposed biosimilar candidate to Prolia® & Xgeva®, developed by Alvotech hf.
The CRL cites observations from a pre-license inspection of Alvotech's manufacturing facility located in Reykjavik. This development pertains to the regulatory status of the biosimilar candidate in the United States.
See What Deep Dive Gives You — in Seconds
“what happens when you click
Deep Dive “
“what happens when you click Deep Dive “
Instant AI Summary - “Get clean, noise-free earnings breakdowns.”
PDF Insights - “Download detailed, AI-generated reports.”
Metrics Explained -“Key ratios & trends explained in simple language.”
Want to know if this news pushes your stock up or down?
Just tap
