Sandoz makes biological deal in China

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Sandoz makes biological deal in China

Home/Pharma News | Posted 22/02/2019 0 Post your comment

Sandoz has made a deal for copy biological in China in December 2018, and received approval of an extra indication for its biosimilar etanercept in January 2019.

Sandoz, the generics division of Novartis, announced on 19 December 2018 that it had entered into an agreement with China-based Gan & Lee to commercialize its biosimilar insulins used in patients with type 1 and type 2 diabetes. Sandoz says its biosimilars are currently in early and clinical stages of development for the European Union (EU), United States (US) and other key territories.

Gan & Lee is a leading insulin supplier with more than 20 years’ experience in insulins and production capacity. The deal aims to bring to market biosimilars of glargine, lispro and aspart.

Under the terms of the agreement, Sandoz will be responsible for commercializing the biosimilars in the EU, US, Switzerland, Japan, South Korea, Canada, Australia and New Zealand. Gan & Lee will be responsible for manufacturing and development, with support from Sandoz, and has to adhere to the stringent manufacturing requirements established for Sandoz biosimilars.

Sandoz has also received approval from Health Canada for an extra indication for another of its biosimilars. On 21 January 2019, Sandoz Canada announced that it had received approval from Health Canada for Erelzi (etanercept) in the treatment of psoriatic arthritis in adult patients.

Sandoz also made a deal with Indian similar biologics’ developer Biocon in January 2018 [1]. Biocon’s insulin glargine biosimilar, Semglee (MYL 1501D), was approved by the European Commission (EC) in March 2018 [2], while its insulin lispro product is still under development.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biocon and Sandoz join forces for global next-generation biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 22]. Available from: www.gabionline.net/Pharma-News/Biocon-and-Sandoz-join-forces-for-global-next-generation-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Insulin biosimilar Semglee gains EC and Australian approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 22]. Available from: www.gabionline.net/Biosimilars/News/Insulin-biosimilar-Semglee-gains-EC-and-Australian-approval

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Source: Sandoz