Sandoz, Gan & Lee enter agreement to market insulin biosimilars

Sandoz on Wednesday announced an agreement with Gan & Lee Pharmaceuticals to commercialize biosimilar versions of insulins used to treat patients with type 1 and type 2 diabetes, according to an industry press release.

The agreement covers biosimilar insulins in early and clinical development for the European Union and the United States for the top three selling branded insulins by sales: glargine (Lantus, Sanofi), lispro (Humalog, Eli Lilly) and aspart (NovoLog, Novo Nordisk). Sandoz, which currently has eight marketed biosimilars, is a division of Novartis Group.

Gan & Lee is a leading insulin supplier headquartered in China with more than 20 years’ experience in insulins and production capacity, according to Sandoz. Under the terms of the agreement, Sandoz will be fully responsible for commercializing these medicines in the EU, U.S., 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.

“Across the world, people suffering from diabetes still face very real access challenges,” Richard Francis, CEO of Sandoz, said in the release. “In fact, U.S. 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. 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.”

Earlier this month, the FDA released guidance documents outlining a new pathway for biologic products aimed at promoting competition and lower prices for drugs with historically high list prices, including insulin. As , starting in March 2020, the approved marketing applications for a small subset of “biological products” such as insulin and human growth hormone — currently approved as drugs under section 505 of the FDA’s Federal Food, Drug, and Cosmetic Act — will be deemed to be biologics licenses under section 351 of the Public Health Service Act. In a statement, the FDA’s commissioner said the new pathway should help usher in a new era of competition for insulin products that will lead to lower prices and better access.

“Tackling the personal and health care burden of diabetes has become a global priority,” Stefan Hendriks, global head of biopharmaceuticals for Sandoz, said in the release. “With a majority of insulin therapies offered by just a few companies, health care systems and the insulin supply are under increasing pressure to meet the growing demands. 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.” – by Regina Schaffer