Blitz Bureau
NEW DELHI: Biocon Biologics has expanded its in-licensing agreement with Fujifilm Kyowa Kirin Biologics (FKB) to secure full and exclusive global rights to Hulio, its biosimilar version of adalimumab. The move gives the Bengaluru-based company end-to-end control over manufacturing, development and commercialisation of the product, marking a shift from its earlier role that was limited to commercial rights, reports The Financial Express.
The agreement supersedes the existing collaboration between the two companies, under which FKB shift to end-to-end ownership
As per the exchange filing, Biocon Biologics will take responsibility across the product lifecycle, which includes manufacturing and any additional development activities. Commercial production of the biosimilar will commence at Biocon Biologics’ facilities after successful technology transfer and regulatory approvals, the filing added.
FKB will continue to 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 along with royalties on sales to FKB for a specified tenure.
Strategic rationale
Shreehas Tambe, Chief Eecutive Officer and Managing Director of Biocon Biologics, said the expanded agreement provides the company with manufacturing rights and end-to-end control over biosimilar adalimumab. According to him, the move improves flexibility and cost efficiency and aligns with the company’s focus on expanding access to high-quality biologics for patients with inflammatory diseases globally.
Biocon Biologics first acquired the global commercial rights to biosimilar adalimumab in 2022 as part of its acquisition of Viatris’ global biosimilars business. Viatris had previously in-licensed the product from FKB. Under that earlier structure, FKB retained manufacturing responsibilities while Biocon Biologics held commercial rights for Hulio.
Adalimumab is one of three immunology biosimilars in Biocon Biologics’ portfolio. The company positions the asset as part of its broader strategy to expand access to biologics for immune-mediated diseases worldwide.
Biocon Biologics, a subsidiary of Biocon Ltd, said it has commercialised 10 biosimilars to date and serves more than 6.3 million patients across over 120 countries. It has a pipeline of more than 20 biosimilar assets spanning multiple therapy areas, including immunology, oncology and diabetology.
