Sandoz enters into commercialization and supply agreement for insulin biosimilars, anticipating growing demand as diabetes burden rises

Novartis International AG / Sandoz enters into commercialization and supply agreement for insulin biosimilars, anticipating growing demand as diabetes burden rises . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• Agreement covers biosimilar insulins in early and clinical development for the top three selling branded insulins by sales: glargine, lispro and aspart

Over 400 million people worldwide have diabetes and the amount of insulin required to treat type 2 diabetes alone is expected to increase by more than 20% from 2018 to 2030[1],[2]

Sandoz continues to strategically expand their biosimilars portfolio, with eight marketed biosimilars and a robust pipeline, showing ongoing commitment to accessible innovation

Holzkirchen, Germany, December 19, 2018 - Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that it has entered into an agreement to commercialize biosimilar versions of insulins used in patients with type 1 and type 2 diabetes. These medicines are currently in early and clinical stages of development for the European Union (EU), United States (US) and other key territories.

The commercialization and supply agreement with Gan & Lee aims at bringing to market biosimilar versions of glargine, lispro and aspart, the three top insulin medicines by sales. Gan & Lee is a leading insulin supplier headquartered in China with more than 20 years' experience in insulins and production capacity with attractive cost of goods sold (COGS) structures. Under the terms of the agreement, Sandoz will be fully responsible for commercializing these medicines 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 shall adhere to the stringent manufacturing requirements established for Sandoz biosimilars. Other specific terms of the agreement are confidential.

In 2015, total global health expenditure due to diabetes was estimated at 673 billion US dollars, roughly 12% of overall global health expenditure[3]. The concerns on insulin affordability have been increasingly noted with the US Food and Drug Administration stating in December 2018 that "access to affordable insulin is literally a matter of life and death for (certain) Americans[4]."