On 29 August 2024, Biocon Ltd announced that it has signed a patent settlement and licence agreement with Janssen which enables Biocon to commercialise Bmab 1200 (ustekinumab), biosimilar to Janssen’s Stelara®, in Europe, the United Kingdom, Canada and Japan. Biocon has submitted regulatory applications in each of these jurisdictions.
The Biocon-Janssen patent settlement and licence agreement follows the US settlement agreement in February 2024 enabling Biocon to launch Bmab 1200 in the US in February 2025. In May 2024, Biocon announced that the FDA accepted its BLA for Bmab 1200 for review under the 351(k) pathway.
Biocon reported in August 2024 year-on-year consolidated revenue growth of 30% for Q2 2024, with its biosimilars business delivering year-on-year growth of 11% compared with the same quarter last year.