Biocon Biologics Secures Global Rights to Adalimumab Biosimilar

Biocon Biologics has secured full and exclusive global rights to its biosimilar Adalimumab, marketed as Hulio, strengthening its control over one of the world’s most widely used biologic therapies. The rights were obtained through an expanded in-licensing agreement with Fujifilm Kyowa Kirin Biologics (FKB), as disclosed in a regulatory filing.

The revised agreement replaces the earlier partnership structure and grants Biocon Biologics end-to-end ownership of the product, covering manufacturing, global commercialisation, and future development. With this arrangement, the company gains direct authority across the entire value chain, allowing tighter coordination between production, regulatory planning, and market access strategies in multiple geographies.

Under the terms of the agreement, FKB will continue to provide support in certain development-related activities and will offset specific associated costs. In exchange, Biocon Biologics will pay a technology licensing fee and sales-linked royalties to FKB for a defined duration. The financial structure aligns incentives while enabling Biocon Biologics to transition Hulio fully into its internal manufacturing and supply ecosystem.

Commercial manufacturing of the biosimilar is expected to shift to Biocon Biologics’ facilities after completion of technology transfer and receipt of necessary regulatory approvals. The move to in-house production is expected to improve supply reliability, enhance cost control, and support broader geographic expansion of the product.

Adalimumab is a monoclonal antibody used in the treatment of chronic inflammatory conditions such as rheumatoid arthritis, psoriasis, ankylosing spondylitis, and inflammatory bowel disease. Biosimilars to Adalimumab have become a key focus for healthcare systems globally as they help reduce treatment costs while maintaining clinical equivalence to originator biologics.

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Biocon Biologics had earlier obtained commercial rights to the Adalimumab biosimilar portfolio through its acquisition of Viatris’ global biosimilars business. Securing full global rights further consolidates its position in the competitive biosimilars market and supports its long-term strategy of expanding access to affordable biologic medicines worldwide.