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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 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.
Ustekinumab is a human monoclonal antibody targeting IL-12 and IL-23.
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