HOLZKIRCHEN, Germany — 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 (E.U.), United States (U.S.) 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. The concerns on insulin affordability have been increasingly noted with the U.S. Food and Drug Administration stating in December 2018 that “access to affordable insulin is literally a matter of life and death for (certain) Americans.”

Sandoz has significant experience disrupting and transforming the healthcare landscape with off-patent medicines including generics, biosimilars and most recently digital therapeutics. This agreement enables Sandoz to expand the existing endocrinology portfolio over the long-term, in-line with its strategy to expand its biosimilar business, and enter the insulins business at attractive investment terms. It also builds on the scientific and commercial expertise of Sandoz, including the approval and launch of eight biosimilar medicines, while leveraging the collaborator’s experience in developing quality insulin medicines and high-volume manufacturing.

When the pancreas does not produce enough insulin, a hormone that regulates blood sugar, a serious chronic disease called diabetes can occur. It is estimated that more than 400 million adults worldwide are living with diabetes, and that number is expected to rise. People with diabetes may develop blindness, kidney failure, and cardiovascular disease.

“Across the world, people suffering from diabetes still face very real access challenges. In fact, US patients have reported taking less insulin than recommended by their doctor because they couldn’t afford it – putting them at higher risk for serious complications,” said Richard Francis, CEO, Sandoz. “At Sandoz, we have significant experience disrupting and transforming marketplaces, and look forward to extending access for the more than 420 million people worldwide suffering from diabetes.”

“Tackling the personal and healthcare burden of diabetes has become a global priority. With a majority of insulin therapy offered by just a few companies, healthcare systems and the insulin supply are under increasing pressure to meet the growing demands[1],[2],” said Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz. “As the pioneer and global leader in biosimilars, Sandoz is proud to expand our endocrinology portfolio into insulins to help people living with diabetes access the medicines they need for the long-term.”