On 26 October 2026, Biocon announced that it has signed a licence agreement with Janssen clearing the way for the commercialization of Yesintek™, biosimilar to Janssen’s Stelara® (ustekinumab), in Australia, Brazil, China, Hong Kong, Israel, Mexico, New Zealand, South Korea and Kazakhstan. Under the agreement, Biocon is permitted to commercialise Yesintek™ in the relevant countries “with immediate effect”.
Biocon first launched Yesintek™ in the US in February 2025 (in PFS and vial presentations), following Yesintek™’s original FDA approval in November 2024. The timing of Biocon’s US launch was governed by a US settlement and licence agreement with Janssen (entered in February 2024), including to resolve an Inter Partes Review Petition.
In August 2024, Biocon announced that it had signed a patent settlement and licence agreement with Janssen for Canada, Japan, Europe and the UK. Yesintek™ was launched in Canada in October 2025 and was approved in Europe in February 2025 and in Japan in December 2024 (announced January 2025).
Yesintek™ was approved in Australia in April 2026 and was recommended for listing on the Pharmaceutical Benefits Scheme at the July 2026 meeting of the Pharmaceutical Benefits Advisory Committee. It is to be supplied in Australia by Biocon’s local partner Generic Health.