Bengaluru : Biocon Biologics Ltd, a fully integrated global biosimilars company and subsidiary of Biocon Ltd, signed today a Distribution Agreement with Sandoz, granting the Company the exclusive rights to promote, sell and distribute “Adalimumab BS for subcutaneous injection [FKB]”*1 in Japan. Based on this Agreement, Viatris has completed marketing and promotion of the product as of December 15, 2023, but will continue to provide transition support until Sandoz will gradually assume responsibilities for the product starting February 15, 2024.
Biocon Biologics has acquired the global biosimilars portfolio of Viatris including Adalimumab. Fujifilm Kyowa Kirin Biologics Co. Ltd., the developer of the drug, has concluded an exclusive global marketing license agreement with Biocon Biologics Ltd affiliate.
Adalimumab BS for subcutaneous injection [FKB] is a biosimilar of Humira® (generic name: adalimumab (genetical recombination)) and is indicated for immune-related diseases such as rheumatoid arthritis, psoriasis vulgaris, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. Sandoz is committed to further strengthening its product pipeline to drive sustainable business growth. The transfer of the distribution rights of this product is part of this strategy, and its addition to the product portfolio will strengthen Sandoz’s immunology and biosimilar portfolio.
Biocon Biologics recently announced the successful completion of its integration of the acquired Viatris’ biosimilars business in 120 countries ahead of schedule, marking a significant milestone in the Company’s journey as a fully integrated, global biosimilars enterprise. At a global level, Biocon Biologics has a robust pipeline of 20 assets for diabetology, oncology, immunology, and ophthalmology. Serving over 5.7M patients annually, the Company is committed to providing access to high-quality therapies and solutions to patients, healthcare systems and governments across the globe.
Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably across a range of areas including immunology, oncology, supportive care, and endocrinology. Since launching the first biosimilar in Europe in 2006, Sandoz has helped to create early and expanded patient access to life-altering medicines while increasing healthcare savings and creating competition that fuels further innovation. Sandoz aims to be the most trusted partner and will leverage its global track record and strengths to deliver high-quality medicines to the people of Japan promptly to ensure the sustainability of the Japanese healthcare system.
Applicable Products
| Product | Packing |
| Adalimumab BS Subcutaneous Injection 20mg Syringe 0.4mL [FKB] | 1 syringe |
| Adalimumab BS Subcutaneous Injection 40mg Syringe 0.8mL [FKB] | 1 syringe |
| Adalimumab BS Subcutaneous Injection 40mg Pen 0.8mL [FKB] | 1 pen |
*1 Fujifilm Kyowa Kirin Biologics Co. Ltd. is a Marketing Authorization Holder in Japan.
