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.
References
AMCP Posters Tackle Interchangeability and Medicaid, Factors Driving Biosimilar Access
April 24th 2024Two posters from the Academy of Managed Care Pharmacy (AMCP) annual meeting explore how an interchangeable insulin glargine biosimilar plays into Medicaid budgets and the top factors driving access to biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
The 6 Key Policy Factors to Ensure Biosimilar Market Sustainability
April 16th 2024Magnus Bodin, senior director and head of international access and policy at Biogen, presented warning signs for unsustainable biosimilar markets as well as key factors needed to create effective policies and future-proof biosimilar markets globally.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.
Rising Biosimilar Adoption for an Italian Payer Will Benefit National Health Care System, Patients
April 9th 2024Data from 2021 and 2022 indicates increasing biosimilar use in an Italian health care company, with potential for full adoption in the future, benefiting both the National Health System and citizens through efficient and sustainable health care policies.