Biocon Biologics Secures Global Rights To Biosimilar Adalimumab From FKB

Biocon Biologics Limited, subsidiary of Biocon Ltd, has secured full and exclusive global rights for Hulio (biosimilar Adalimumab) from Fujifilm Kyowa Kirin Biologics Co,  the company said in exchange filing,

Under this new agreement, Biocon Biologics will assume end-to-end responsibility for manufacturing and commercialization, along with rights for any additional development activities. The company stated that this new agreement supersedes the existing collaboration agreement between Biocon Biologics and FKB for biosimilar Adalimumab, under which Biocon Biologics previously held only commercialization rights.

Under the terms outlined in the officially released documents, 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 license fee and royalties on sales to FKB for a specified tenure.

The commercial production of biosimilar Adalimumab at Biocon Biologics’ facilities will commence following successful technology transfer and regulatory approvals.

Biocon Biologics 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 FKB. Under the earlier arrangement, FKB manufactured and supplied the product to Biocon Biologics, which holds global commercial rights for Hulio. Adalimumab is one of the three immunology biosimilars in Biocon Biologics’ overall portfolio, which underscores the company’s strategic focus on expanding access to biologics for immune-mediated diseases worldwide.