Policy updates around the world have garnered a lot of attention during March, and suggestions for practices could influence biosimilar adoption and acceptance.
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.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
British Columbia’s Biosimilar Policy Shows No Impact on Hospital Visits
May 28th 2025Despite a dramatic shift toward biosimilar use following British Columbia’s policy, researchers found no rise in hospital visits or complications, underscoring the real-world reliability of etanercept biosimilars in managing inflammatory arthritis.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.