Sandoz to Partner With Gan and Lee to Commercialize Biosimilar Insulins in the US and Abroad

Sandoz announced yesterday that it has entered into an agreement with Chinese drug maker Gan and Lee to commercialize biosimilar insulins to treat patients with type 1 and type 2 diabetes.

Under the terms of the agreement, Gan and Lee’s insulin products, referencing insulin glargine, insulin lispro, and insulin aspart—the top 3 insulin therapies by sales—will be commercialized by Sandoz in the European Union, United States, Switzerland, Japan, South Korea, Canada, Australia, and New Zealand. Gan and Lee will hold responsibility for manufacturing and development of the products and will adhere to Sandoz’s manufacturing requirements.

In a statement announcing the agreement, Richard Francis, CEO of Sandoz, explained that the agreement has the potential to increase patient access to these crucial products. Said Francis, "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. [We] look forward to extending access for the more than 420 million people worldwide suffering from diabetes."

Stefan Hendriks, global head of biopharmaceuticals at Sandoz, added that Sandoz is making addressing the personal and healthcare burden of diabetes a priority. Given the fact that most insulin therapies are manufactured by just a few companies worldwide, the agreement with Gan and Lee allows Sandoz to expand its portfolio of products to help meet the increasing demand for insulin.

In the European Union, as in much of the world, products that reference insulins are treated as biosimilars under national regulatory pathways. However, in the United States, insulin products are currently regulated as drugs, and products developed referencing them are regulated as follow-ons. That is set to change in 2020, however, when insulins, proteins, and chemically synthesized polypeptides will be transitioned to regulation as biologics and biosimilars under the Biologics Price Competition and Innovation Act.

Earlier this month, the FDA published 4 new guidance documents on biosimilars that address industry’s questions about the transition process and also issued a proposed rule that would amend the agency’s definition of a biologic product in order to encompass insulins and other applicable products.

In a statement announcing the new guidance and proposed rule, FDA Commissioner Scott Gottlieb, MD, said that the transition could make it easier for developers to bring to market cheaper interchangeable insulin products that can be substituted at the pharmacy level, potentially increasing access and lowering costs for US patients with diabetes.