Biocon rises 3% after its arm gets US FDA nod for psoriasis drug YESINTEK

Biocon shares gained 2.8 per cent on BSE in Monday's trade and logged an intraday high of Rs 375.05 per share. The buying interest sparked after the company arm Biocon Biologics received approval from the US Food and Drug Administration (US FDA) for YESINTEK (Ustekinumab-kfce), a biosimilar to the reference product Stelara (Ustekinumab).

 

YESINTEK is a monoclonal antibody, approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. 

 

Around 9:27 AM, Biocon share price was up 1.32 per cent at Rs 369.6 per share on BSE. In comparison, the BSE Sensex was up 0.58 per cent at 79,338.21. The market capitalisation of the company stood at Rs 44,374.18 crore. The 52-week high of the stock stood at Rs 395.65 per share and the 52-week low was at Rs 236.8 per share. 

 

 

"Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd announced today that the U.S. Food and Drug Administration (FDA) has approved YESINTEK™ (Ustekinumab-kfce), a biosimilar to the reference product, Stelara (Ustekinumab)," the filing read. 

  The filing added: Biocon Biologics Ltd had previously notified on February 29, 2024, that the company had entered into a settlement and licensing agreement with Janssen. Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) to commercialise YESINTEK in the United States of America no later than on February 22, 2025, upon approval from the US FDA.

 

Biocon Biologics, a subsidiary of Biocon Limited, specialises in the development, manufacturing, and commercialisation of biosimilars, which are affordable alternatives to expensive biologic drugs. 

 

The company focuses on therapeutic areas like oncology, diabetes, immunology, and nephrology, offering products such as insulin glargine, trastuzumab, and bevacizumab. Through strategic global partnerships, particularly with Viatris (formerly Mylan), Biocon Biologics has expanded its reach in both emerging and developed markets. 

 

Its manufacturing facilities meet international standards, and the company has successfully obtained regulatory approvals from agencies like the US FDA and EMA. Additionally, Biocon Biologics emphasises sustainability in its operations.

 

Biocon is a global biopharmaceutical company based in India, primarily focused on the development and production of biologics, biosimilars, and small molecules. Founded in 1978 by Kiran Mazumdar-Shaw, Biocon has become one of the leading biotechnology companies in the world. The company is known for its work in areas such as oncology, immunology, and diabetes, and has a strong presence in both the domestic and international markets.

 

In the past one year, Biocon shares have gained 51.5 per cent against Sensex's rise of 18 per cent.