Biocon Biologics Limited, a fully integrated global biosimilars company and 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.. With this agreement, Biocon Biologics will now assume complete end-to-end responsibility for manufacturing and commercialization, along with rights for any additional development activities related to the product.
The new arrangement replaces the earlier collaboration between Biocon Biologics and FKB for biosimilar Adalimumab, under which Biocon Biologics had only commercialization rights while manufacturing was carried out by FKB. The revised agreement provides Biocon Biologics greater control across the value chain, strengthening its long-term biosimilars strategy.
As part of the agreement, FKB will continue to participate in the development of Hulio 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 defined tenure. Commercial production of biosimilar Adalimumab is expected to begin at Biocon Biologics’ facilities after successful technology transfer and receipt of regulatory approvals.
Biocon Biologics initially obtained the commercial rights to biosimilar Adalimumab in 2022 through its acquisition of the global biosimilars business of Viatris. Viatris had earlier in-licensed the product from FKB, under which FKB manufactured and supplied Hulio while Biocon Biologics held global commercialization rights.
