Sandoz licenses its rituximab biosimilar to Kyowa Hakko Kirin in Japan

January 27, 2016 7:08 AM

Sandoz, a Novartis company, announced that it has entered into an exclusive license agreement with Kyowa Hakko Kirin Co., Ltd for the distribution and promotion of its biosimilar rituximab – a monoclonal antibody, in Japan.

Under the terms of the agreement, Sandoz will file for marketing authorization of biosimilar rituximab and its manufacture if approved. Kyowa Hakko Kirin will be responsible for all sales, marketing and promotion activities in Japan.

Kyowa Hakko Kirin will pay Sandoz an up-front fee, subsequent payments for regulatory filing, regulatory approval, success-based milestones, royalties as well as defined supply price for every order.

“The agreement with Kyowa Hakko Kirin announced today demonstrates our commitment to expanding patient access to biosimilars across the world” said Carol Lynch, Global Head Biopharmaceutical & Oncology Injectables, Sandoz. “If approved, biosimilar rituximab means that healthcare professionals in Japan will have more choice in what they prescribe to their patients with hematological cancers.”

Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. Sandoz has a leading pipeline and plans to make 10 regulatory filings over a three year period (2015-2017).

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