Biosimilars Policy Roundup: March 2023

Policy updates around the world have garnered a lot of attention during March, and suggestions for practices could influence biosimilar adoption and acceptance.

International Policy Updates

Canada had a big month as 2 jurisdictions, a province and a territory, announced that they will implement biosimilar switching policies. The jurisdictions join 8 others.

Newfoundland and Labrador was first, and its policy concerns patients currently or in need of treatment using Copaxone (glatiramer acetate), Enbrel (etanercept), Humalog (insulin lispro), Humira (adalimumab), Lantus (insuling glargine), Lovenox (enoxaparin sodium), NovoRapid (insulin aspart), Remicade (infliximab), and Rituxan (rituximab). Patients currently taking one of the aforementioned originators will have until March 31, 2023, to switch to a biosimilar or lose coverage.

The Yukon government announced its plan shortly after. Initally, the policy will only apply to adalimumab and insulin glargine biosimilars but will expand to include other products in the future. Patients on Humira (reference adalimumab) or Lantus (reference insulin glargine) will have 6 months to transition to a biosimilar, and treatment-naïve patients in need of therapy with either agent will automatically be prescribed a biosimilar.

In Belgium, researchers proposed new policy recommendations in a study to realign financial incentives and provide more information on biosimilars to medical professionals, especially on switching and using structured discussions between health care professional stakeholders.

Additionally, study authors in China made recommendations on how to improve the country’s biosimilar regulatory system and refine biosimilar guidelines. Some of the recommendations addressed label managing, nomenclature policies, and defining interchangeability.

Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, examined recent guidelines from the World Health Organization (WHO) and how they view interchangeability and animal study requirements. The article was the second part of a 2-part series on the new recommendations.

New US Legislation and Suggestions for Practices

A new bill (the Increasing Access to Biosimilars Act of 2023; HR 1352) seeking to establish a demonstration project that would establish a shared savings model for biosimilars under Medicare was introduced to Congress. The bill was written by Representative Richard Hudson, R-North Carolina, and was referred to the Committee on Energy and Commerce and the Committee on Ways and Means.

At the Festival of Biologics, 2 presentations focused on possible policies that practices can implement to boost biosimilar adoption. One focused on the current published evidence regarding biosimilar-to-biosimilar switching. Although there isn’t much published work, there is a lot of real-world evidence establishing the safety of this type of medication switching from US Veteran Affairs and European countries with tender systems.

During the other presentation, Julie Reed, executive director of the Biosimilars Forum, warned that without nationwide policy changes to remove barriers to biosimilar adoption, such as pharmacy benefit manager interference and patent thickets, manufacturers may not want to continue investing in biosimilar development.