Dr Reddy's arm receives USFDA complete response letter for AVT03 biosimilar application

Hyderabad-based drug major Dr Reddy’s Laboratories Ltd on Wednesday (December 31) informed that its wholly owned subsidiary, Dr Reddy's Laboratories SA, Switzerland, has received a Complete Response Letter from the United States Food and Drug Administration for its Biologics License Application for AVT03.

AVT03 is a proposed biosimilar candidate to Prolia and Xgeva, developed by Alvotech hf. The application was submitted by Dr Reddy’s Swiss. According to the disclosure, the Complete Response Letter

refers to observations arising from a pre-license inspection conducted by the USFDA at Alvotech's manufacturing facility located in Reykjavik.

Second Quarter Results

Dr Reddy’s Laboratories reported a net profit of ₹1,347 crore for the September quarter (Q2 FY26), up 7.3% year-on-year from ₹1,256 crore, though slightly below the CNBC-TV18 poll estimate of ₹1,403.7 crore.

Also Read: US FDA issues Form 483 to Dr Reddy’s Andhra Pradesh formulations unit

The company’s revenue increased 9.8% YoY to ₹8,828 crore, compared with ₹8,038 crore in the same period last year, surpassing the poll estimate of ₹8,595.4 crore.

Operating performance showed a mixed trend, with EBITDA at ₹2,010 crore, down 3.2% YoY from ₹2,076.8 crore and below the poll estimate of ₹2,208.5 crore. EBITDA margin stood at 22.8%, compared with 25.8% YoY and 25.7% expected by analysts.

For H1 FY26, consolidated revenues were ₹17,350 crore, reflecting an 11% YoY growth. Growth was broad-based across key markets, except North America Generics, which faced higher price erosion in select products and lower lenalidomide sales. The acquired Consumer Healthcare portfolio in Nicotine Replacement Therapy (NRT) contributed positively to overall performance.

Shares of Dr Reddy's Laboratories Ltd ended at ₹1,273.00, down by ₹7.20, or 0.57%, on the BSE.

Also Read: Dr Reddy's Laboratories Q1 | Revenue jumps over 11% to ₹8,545 crore but margin contracts