Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and Winship Cancer Institute, describes how local health policy initiatives can help providers and patients feel more comfortable with the idea of interchangeable biosimilars.
Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and Winship Cancer Institute, describes how local health policy initiatives can help providers and patients feel more comfortable with the idea of interchangeable biosimilars.
Transcript
What policy initiatives can be adopted to ensure that concerns regarding interchangeability are mitigated and that patients are confident in the efficacy of all biosimilars?
So, I think there's policies both nationally [and] locally in our own health systems where we can drive forward the most change. And I think we need to learn from our European colleagues: How do we leverage real-world evidence so people can understand the benefits of it?
I think when we look at policies too, we recognize that with interchangeability by the FDA, not every [company is] going for it, and we recognize that it takes extra money to get an FDA approval with interchangeability.
So, how do we leverage some of our pharmacy and therapeutics policies to determine that if biosimilars are approved, we consider them equally efficacious? And that allows us to go ahead and interchange products upon dispensation with approval of the medical executive board. I think that really creates change much faster. We don't have to wait on certain therapies being interchangeable or not interchangeable, and at the end of the day, it allows us to drive consistent care.
And lastly, how do we leverage data from curative intent patient populations to noncurative intent patient populations and across different disease states, both oncology and nononcology?
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.