Biocon Biologics’ YESINTEK Biosimilar Receives Positive EMA Opinion for Approval

Biocon Biologics, a subsidiary of Biocon Ltd, announces that its biosimilar YESINTEK (Ustekinumab) has received a positive opinion from the European Medicines Agency’s CHMP, following successful clinical trials.

Details of EMA Approval

This biosimilar is designed to treat adults and children with plaque psoriasis, as well as adults with psoriatic arthritis and Crohn’s disease.

The CHMP’s recommendation is based on clinical studies showing that YESINTEK has a comparable pharmacokinetic, safety, efficacy, and immunogenicity profile to the original product.

After receiving approval from the European Commission, detailed guidance on YESINTEK’s use will be available in the European Public Assessment Report (EPAR) in all official European Union languages.

This recommendation follows a similar approval from the USFDA earlier this month, further advancing Biocon Biologics’ position in the global biosimilars market.

Biocon Q2FY25 Financial Highlights

For the quarter ended September 2024, Biocon reported flat total revenue of ₹3,623 crore, with a 4% year-on-year growth in revenue from operations at ₹3,590 crore.

However, net profit declined sharply by 84.3% YoY to ₹27.1 crore, and profit before tax (PBT) fell 54.08% YoY to ₹98.4 crore.

The company’s EBITDA stood at ₹718 crore, reflecting a 20% margin. Despite the revenue stability, the significant drop in profitability was attributed to higher expenses and margin pressures across its business segments.

Biocon Share Price Performance

On December 16, 2024, Biocon’s share price traded 0.20% higher at ₹353.50 at 12:50 PM on the NSE. The stock opened at ₹357 higher from its previous close of ₹352.80.

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