Biocon Biologics has secured full global rights to Hulio, its biosimilar Adalimumab, through an expanded agreement with Fujifilm Kyowa Kirin Biologics (FKB). This grants Biocon Biologics end-to-end control over manufacturing and commercialization. FKB will participate in development, offsetting costs, while Biocon Biologics will pay a technology license fee and royalties. Commercial production will commence after technology transfer and regulatory approvals.
Expanded Biosimilar Agreement
Biocon Biologics Limited has announced it has secured full and exclusive global rights for Hulio® (biosimilar Adalimumab) from Fujifilm Kyowa Kirin Biologics Co., Ltd. (FKB). This announcement was made on December 23, 2025.
Key Terms of the Agreement
Under the new agreement, Biocon Biologics will assume end-to-end responsibility for manufacturing and commercialization, including rights for additional development activities. This agreement supersedes the previous collaboration, granting Biocon Biologics expanded control.
FKB will participate in the product’s development and offset certain development costs incurred by Biocon Biologics. In return, Biocon Biologics will pay a technology license fee and royalties on sales to FKB for a specified period.
Manufacturing and Production
Commercial production of biosimilar Adalimumab will commence at Biocon Biologics’ facilities, following successful technology transfer and regulatory approvals. This will give Biocon greater flexibility.
Executive Commentary
Shreehas Tambe, CEO & Managing Director of Biocon Biologics Limited, stated, “This agreement with FKB provides Biocon Biologics the manufacturing rights to biosimilar Adalimumab, granting us end-to-end control over the product. This strategic move enhances flexibility and cost efficiency, reinforcing our commitment to expanding affordable access to high-quality biologics for patients with inflammatory diseases globally.”
Strategic Focus
Adalimumab is one of the three immunology biosimilars in Biocon Biologics’ portfolio, underscoring the Company’s strategic focus on expanding access to biologics for immune-mediated diseases worldwide.
Source: BSE