Biocon Biologics, Sandoz sign pact to distribute adalimumab biosimilar Humira in Japan

The agreement, effective immediately, marks a strategic move to bolster the presence of Biocon Biologics in the Japanese market

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26 Aug, 2025 12:21

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Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, has inked a significant distribution agreement with Sandoz, securing exclusive rights for the promotion, sale, and distribution of "Adalimumab BS for subcutaneous injection [FKB]" in Japan.

The agreement, effective immediately, marks a strategic move to bolster the presence of Biocon Biologics in the Japanese market. Sandoz will have the exclusive right to promote sell and distribute the product in Japan according to the pact.

Adalimumab BS for subcutaneous injection [FKB] is a biosimilar of Humira (generic name: adalimumab (genetical recombination)), offering therapeutic solutions for immune-related diseases such as rheumatoid arthritis, psoriasis vulgaris, ankylosing spondylitis, Crohn's disease, and ulcerative colitis. The biosimilar's entry into the Japanese market is poised to address the unmet medical needs of patients grappling with these challenging conditions.

The Adalimumab Biosimilar Market Size is valued at $ 613.28 million in 2022 and is predicted to reach $3954.75 million by the year 2031 at a 23.2  percent CAGR during the forecast period for 2023-2031.

This latest development follows Biocon Biologics' acquisition of Viatris' global biosimilar portfolio, which includes the coveted Adalimumab. Fujifilm Kyowa Kirin Biologics Co Ltd, the developer of the drug, has concurrently entered into an exclusive global marketing license agreement with Biocon Biologics Ltd affiliate.

Under the terms of the agreement, Viatris has successfully completed the marketing and promotion of the biosimilar product as of December 15, 2023. However, Viatris will continue to provide transition support until February 15, 2024, after which Sandoz will gradually assume full responsibility for the distribution of Adalimumab BS.

Biocon Biologics recently completed its integration of the acquired Viatris’ biosimilars business in 120 countries ahead of schedule, marking a significant milestone in its journey. At a global level, Biocon Biologics has a robust pipeline of 20 assets for diabetology, oncology, immunology, and ophthalmology.

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