Biocon Biologics secures global manufacturing and commercial rights for Hulio

Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon, has announced that it has secured full and exclusive global rights for Hulio, a biosimilar of Adalimumab, from Fujifilm Kyowa Kirin Biologics Co., Ltd. (FKB). Under the new agreement, Biocon Biologics will assume end-to-end responsibility for manufacturing and commercialisation, along with rights for any additional development activities.

The agreement supersedes the existing collaboration between Biocon Biologics and FKB for biosimilar Adalimumab, under which Biocon Biologics held only commercialisation rights. As per the revised terms, FKB will participate in the development of the product and will offset certain development costs incurred by Biocon Biologics. In return, Biocon Biologics will pay a technology licence fee and royalties on sales to FKB for a specified tenure. Commercial production of the biosimilar Adalimumab at Biocon Biologics’ facilities will commence following successful technology transfer and receipt of regulatory approvals.

Commenting on the development, Shreehas Tambe, CEO and Managing Director, Biocon Biologics Limited, said, “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.”

Biocon Biologics initially acquired the commercial rights to biosimilar Adalimumab in 2022 through its acquisition of Viatris’ global biosimilars business. Viatris had earlier in-licensed the product from FKB. Under the earlier arrangement, FKB manufactured and supplied the product to Biocon Biologics, which held global commercial rights for Hulio.

Adalimumab is one of the three immunology biosimilars in Biocon Biologics’ portfolio, reflecting the company’s focus on expanding access to biologics for immune-mediated diseases worldwide.