On 23 December 2025, Biocon Biologics announced that is has secured full and exclusive global rights for Hulio®, biosimilar to AbbVie’s Humira® (adalimumab), from Fujifilm Kyowa Kirin Biologics Co., Ltd. (FKB).
Under the new agreement, which supersedes an existing collaboration agreement between the companies which only granted Biocon commercialisation rights, Biocon will now be responsible for both manufacturing and commercialising the product and will also have rights for any additional development activities. FKB will offset certain development costs incurred by Biocon and Biocon will pay a technology licence fee and royalties on sales to FKB for a specified period.
Commercial manufacturing of Hulio® at Biocon’s facilities will commence following completion of technology transfer and regulatory approvals.
Biocon originally acquired the commercialisation rights to biosimilar adalimumab through its acquisition of Viatris’ global biosimilars portfolio in November 2022, and completed the integration of the business in over 70 countries in July 2023, shortly followed by North America in September 2023. Viatris had previously in-licensed the product from FKB.
Hulio® was first approved in Europe in 2018, the US in 2020 and Canada in February 2021.