Dr Reddy's Arm Gets USFDA CRL for AVT03 Biosimilar; Q2 Profit Up 7.3%

• Dr Reddy's Laboratories SA received a Complete Response Letter (CRL) from USFDA for its AVT03 biosimilar application.
• The CRL cited observations from a pre-license inspection at Alvotech's manufacturing facility in Reykjavik.
• Dr Reddy's Q2 FY26 net profit rose 7.3% YoY to ₹1,347 crore, with revenue up 9.8% to ₹8,828 crore, surpassing poll estimates.
• EBITDA for Q2 FY26 declined 3.2% YoY to ₹2,010 crore, and EBITDA margin stood at 22.8%, below analyst expectations.
• H1 FY26 consolidated revenues grew 11% YoY to ₹17,350 crore, driven by broad-based growth except North America Generics.

Why It Matters: USFDA issued a CRL for Dr Reddy's AVT03 biosimilar, while Q2 profits grew despite mixed operating results.