Biocon Biologics Secures Full Global Rights to Biosimilar Adalimumab through Expanded FKB In-Licensing Agreement

Bengaluru, Karnataka, India: December 23, 2025:

Biocon Biologics Limited, a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), today announced that it has secured full and exclusive global rights for Hulio® (biosimilar Adalimumab) from Fujifilm Kyowa Kirin Biologics Co., Ltd. (FKB). 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 new agreement supersedes the existing collaboration agreement between Biocon Biologics and FKB for biosimilar Adalimumab, under which Biocon Biologics only had commercialization rights.

Under the terms of this agreement, FKB will participate in the development of the product and will offset certain development costs incurred by Biocon Biologics. In turn, 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’ facilities will commence following successful technology transfer and regulatory approvals.

Shreehas Tambe, CEO & 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 previously in-licensed the product from FKB. Under the earlier arrangement, FKB manufactures and supplies 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.

About Biocon Biologics Limited

Biocon Biologics Limited, a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its ‘lab to market’ capabilities to serve over 6.3 million patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes.

Biocon Biologics has commercialized 10 biosimilars from its portfolio which are addressing the patients’ needs in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 20+ biosimilar assets across diabetology, oncology, immunology, ophthalmology, bone health and other non-communicable diseases. The Company has many ‘firsts’ to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website: www.bioconbiologics.com; Follow us on  X (formerly Twitter): @BioconBiologics and LinkedIn: Biocon Biologics for company updates.

Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceutical company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the U.S., Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: www.biocon.com  Follow-us on X (formerly Twitter) @bioconlimited and LinkedIn: @BioconLimited for company updates. For FY25 Integrated Annual Report of Biocon click here