Biocon Biologics gets US nod to launch Stelara biosimilar

Biocon Biologics, the subsidiary of Biocon on Saturday has received the USFDA nod to launch the biosimilar version of Janssen's Stelara (Ustekinumab) used for the treatment of autoimmune disorders such as Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.

Biocon Biologics will be able to launch the drug in the US no later than on February 22, 2025, as per the settlement and licensing agreement with Janssen. Stelara is the top selling drug for Janssen with sales of $7 billion in the US in 2023.
The biosimilar will be marketed under brand name Yesintek.


The U.S. FDA has accepted the company’s Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway.

The approval will pave the way for launch of the biosimilar that will aid to revenue and profitability of the company, despite stiff competition from rival biosimilars. USFDA has already approved five biosimilars of Stelara, which are expected to hit the market in the fourth quarter of FY25.

Amgen's Stelara biosimilar, will go first into the market with scheduled launch no later than January 1, 2025.

Biocon Biologics also secured market entry for biosimilar Ustekinumab in Europe, the United Kingdom (UK), Canada, and Japan

Ustekinumab is a human monoclonal antibody that prevents abnormal regulation of interleukin IL-12 and IL-23 associated immune diseases.