Biocon Biologics Limited, a fully integrated global biosimilars company and a subsidiary of Biocon Limited, has secured full and exclusive worldwide rights to Hulio® (biosimilar Adalimumab) from Fujifilm Kyowa Kirin Biologics Co, Ltd (FKB). Under the revised agreement, Biocon Biologics will take complete responsibility for manufacturing, commercialization, and any future development activities related to the product. This new arrangement replaces the earlier collaboration under which Biocon Biologics held only global commercialization rights while manufacturing remained with FKB.
As part of the updated terms, FKB will continue to support product development and will offset certain development-related costs incurred by Biocon Biologics. In return, Biocon Biologics will pay a technology licensing fee and sales-linked royalties to FKB for a defined period. Commercial manufacturing of the biosimilar will commence at Biocon Biologics’ facilities following successful technology transfer and regulatory approvals.
Shreehas Tambe, Chief Executive Officer and Managing Director of Biocon Biologics Limited, said the agreement marks an important strategic step. By gaining manufacturing rights alongside commercialization control, the company achieves end-to-end ownership of the product, improving operational flexibility and cost efficiency while advancing its mission to expand access to affordable, high-quality biologics for patients with inflammatory diseases worldwide.
Biocon Biologics originally obtained global commercial rights to the Adalimumab biosimilar in 2022 through its acquisition of Viatris’ biosimilars business. Prior to that, Viatris had in-licensed the product from FKB.
Under the earlier structure, FKB manufactured and supplied the product while Biocon Biologics managed global commercialization. Adalimumab is one of three immunology biosimilars in Biocon Biologics’ portfolio, reflecting the company’s broader strategy to improve access to biologic therapies for immune-mediated conditions across global markets.
Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars company focused on improving healthcare access and outcomes worldwide. Leveraging end-to-end capabilities from research to commercialization, the company currently serves more than 6.3 million patients across over 120 countries by providing high-quality biosimilars at affordable costs.
Biocon Biologics has commercialized 10 biosimilars to date, with products available in key emerging markets as well as advanced markets including the United States, Europe, Canada, Australia, and Japan. Its pipeline includes more than 20 biosimilar assets spanning diabetology, oncology, immunology, ophthalmology, bone health, and other non-communicable diseases. The company is also committed to advancing environmental, social, and governance priorities aligned with the United Nations Sustainable Development Goals.
