Biocon Biologics Secures Full Global Manufacturing Rights for Adalimumab Biosimilar Hulio
核心洞察
Biocon Biologics (搜索) has secured full and exclusive global rights for Hulio, a biosimilar of adalimumab, from Fujifilm Kyowa Kirin Biologics (搜索), gaining end-to-end control over manufacturing and commercialization.
The new agreement supersedes the existing collaboration where Biocon Biologics (搜索) held only commercialization rights, now providing manufacturing rights and enhanced flexibility for cost efficiency.
Commercial production at Biocon Biologics (搜索)' facilities will commence following successful technology transfer and regulatory approvals, reinforcing the company's commitment to expanding affordable access to biologics for inflammatory diseases (搜索).
Biocon Biologics (搜索) has announced a strategic expansion of its adalimumab biosimilar program, securing full and exclusive global rights for Hulio from Fujifilm Kyowa Kirin Biologics (搜索) (FKB). The agreement grants the Indian biosimilars company end-to-end responsibility for manufacturing and commercialization, along with rights for any additional development activities.
Strategic Shift from Commercial to Manufacturing Rights
The new agreement supersedes the existing collaboration between Biocon Biologics (搜索) and FKB for biosimilar adalimumab, under which Biocon Biologics previously held only commercialization rights. Under the revised terms, FKB will participate in product development and will 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 tenure.
Commercial production of biosimilar adalimumab at Biocon Biologics (搜索)' facilities will commence following successful technology transfer and receipt of regulatory approvals.
"This agreement with FKB provides Biocon Biologics (搜索) the manufacturing rights to biosimilar adalimumab, granting us end-to-end control over the product," said Shreehas Tambe, CEO and Managing Director of Biocon Biologics Limited. "This strategic move enhances flexibility and cost efficiency, reinforcing our commitment to expanding affordable access to high-quality biologics for patients with inflammatory diseases (搜索) globally."
Portfolio Development Through Strategic Acquisitions
Biocon Biologics (搜索) initially acquired the commercial rights to biosimilar adalimumab in 2022 through its acquisition of Viatris' global biosimilars business. Viatris had previously in-licensed the product from Fujifilm Kyowa Kirin Biologics (搜索). Under the earlier arrangement, FKB manufactured and supplied the product to Biocon Biologics, which held global commercial rights for Hulio.
Adalimumab is one of three immunology biosimilars in Biocon Biologics (搜索)' overall portfolio, reflecting the company's focus on expanding access to biologics for immune-mediated diseases worldwide. The strategic shift to full manufacturing control positions the company to optimize production efficiency and cost management for this key therapeutic area.