Shares of Biocon rallied 4% on Monday, 2 December, after the company announced that its subsidiary, Biocon Biologics, had received approval from the US Food and Drug Administration (USFDA) for YESINTEK (Ustekinumab-kfce). 

The YESINTEK (Ustekinumab-kfce) is a biosimilar to the reference drug Stelara (Ustekinumab). The YESINTEK is a monoclonal antibody, which is used for treating Crohn’s disease, plaque psoriasis, ulcerative colitis, and psoriatic arthritis. 
 
In its regulatory filing, the company said, “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).”

Biocon Biologics Ltd. had earlier informed the firm on 29 February that the two parties had reached a settlement and licensing agreement with Janssen, the lawsuit further stated. Johnson & Johnson, Janssen Sciences Ireland, and Biotech Inc. (collectively known as Janssen) will commercialize YESINTEK in the United States of America by 22 February 2025, at the latest, following FDA approval.

Developing, producing, and marketing biosimilars—cheap substitutes for pricey biologic medications—is the focus of Biocon Biologics, a division of Biocon Limited. 

The company sells medications such as insulin glargine, trastuzumab, and bevacizumab and focuses on immunology, diabetes, nephrology, and cancer. By means of smart international alliances, especially with Viatris (formerly Mylan), Biocon Biologics has increased its market share in both developed and emerging nations. 
 
The company’s manufacturing facilities are up to international standards, and it has received regulatory clearances from organizations such as the US FDA and EMA. In its activities, Biocon Biologics also places a strong emphasis on sustainability.

A multinational biopharmaceutical corporation with its headquarters in India, Biocon is mainly concerned with the creation and manufacturing of small molecules, biologics, and biosimilars. One of the top biotechnology firms in the world, Biocon was founded in 1978 by Kiran Mazumdar-Shaw. The business is well-known for its work in fields including diabetes, immunology, and oncology, and it is well-established in both the home and foreign markets.

At 11:42 am, the shares of Biocon were trading 3.19% higher at Rs 376.80 on NSE.

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