Although biosimilar insulins are available in Europe, there are none in the United States currently, although that is slated to change.
Biosimilar insulins are expected to facilitate price drops in the insulin market thanks to a new regulatory pathway and nearly all existing patents for insulin products expiring by the end of 2020, according to a recent study of the insulin market.1
“These factors may significantly change the market for insulin—and thus the lives of millions of Americans who depend on it,” wrote the authors, with the American Action Forum.
Roughly 8.3 million US residents currently require insulin to regulate glucose levels, and worldwide insulin use will climb 20% by the year 2030, the report predicted. Although biosimilar insulins are available in Europe, there are none in the United States currently, where the market is dominated by 3 large producers, noted the study.
On March 23, a provision added to the FDA’s Biologics Price Competition and Innovation Act (BPCIA) will go into effect, allowing insulin products to be approved through the biosimilar pathway instead of the small-molecule drug pathway. Investigators said they expect this change to spur the development of insulin biosimilars.
The BPCIA provision also amended the definition of a biological product to now include any “chemically synthesized polypeptides.” This change is expected to simplify the regulatory pathway for gaining approval of chemically synthesized insulins.2
In addition, the FDA has indicated it may allow substitution of biosimilar insulin at the pharmacy without proof of interchangeability, given the long product history of insulin.2 Interchangeability status for biosimilars, which enables product substitution without physician consent, is generally considered valuable for biosimilar manufacturers hoping to gain market access.
Further, the FDA recently issued guidance on when comparative immunogenicity studies are required to support applications for insulin products under the biosimilar approval pathway.
Currently, the 3 main insulin manufacturers are Eli Lilly, Novo Nordisk, and Sanofi, and they represent over 90% of the global insulin market and produce nearly 100% of US insulin supply. Novo Nordisk has the only monopoly, owning all ultra-long-acting insulin products.
Over 100 patents on insulin products remain in force, preventing cheaper insulin products from entering the market and reducing competition. More than 90% of these patents will have expired by the end of 2020, according to the World Health Organization (WHO).
New products may cause older products to be prescribed less frequently or discontinued. Brand availability is a major reason patients may switch insulin products.
Often, newer insulin products don’t offer much improvement over older ones. WHO contends that “price increases may exceed the added value” and “medical innovation should be measured in terms of added clinical value and cost-effectiveness,” the authors wrote.
On top of patents, “periods of exclusivity” granted by the FDA for new biologics can keep biosimlar insulin products from being approved by the FDA for 16 years. Four of those years are granted to keep other companies from filing an application for approval. The other 12 prohibit the FDA from approving a biosimilar application.
“A drug may receive a period of exclusivity even if it does not receive a patent,” investigators said.1
“In some instances, the new version may significantly improve patient health and quality of life and is thus worth more to the patient, but sometimes the improvements are minimal, and the price increase may exceed the added value,” they wrote.
Although patents incentivize innovation and are intended to temporarily protect market share from competitors, patents can be renewed if a company:
However, biosimilar insulin products are projected to lower the cost of insulin and encourage competition in the market.
Follow-on insulin products introduced to date have reduced costs by only 10% to 15%. Investigators contended that “this result may be largely due to the fact that even these follow-on products are manufactured by the 3 primary manufacturers rather than a competitor,” investigators wrote.