On this episode of Not So Different, we discuss some of the global biosimilar policy news that came out during the month of March, including a new bill in Congress and 2 Canadian jurisdictions implementing switching policies.
On this episode of Not So Different, we discuss some of the global biosimilar policy news that came out during the month of March, including a new bill in Congress and 2 Canadian jurisdictions implementing switching policies.
Show notes
Canadian Province Newfoundland and Labrador Adds Biosimilar Switching Policy
Yukon Becomes Tenth Canadian Jurisdiction to Add Biosimilars Switching Policy
Policy Recommendations for Improving Biosimilar Uptake in Belgium
Researchers Recommend Improvements for China’s Biosimilar Regulatory Policies
The Increasing Access to Biosimilars Act of 2023 Introduced to Congress
Published Data Coupled With Real-world Evidence Show Safety of Biosimilar-to-Biosimilar Switching
Uptake Barriers Will Deter Future Competitors From Investing in Biosimilars, Julie Reed Warns
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
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.
BioRationality: Commemorating the 15th Anniversary of the BPCIA
April 8th 2025Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.