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.
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.
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.
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.
Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.
Published on: Dec 16, 2024, 12:52 PM IST
We're Live on WhatsApp! Join our channel for market insights & updates
Get the link to download the App
