There were a variety of developments in the biosimilars space in 2018, and our expert contributors responded to those changes with in-depth insights that reflected the complexity of the biosimilars landscape.
There were a variety of developments in the biosimilars space in 2018, and our expert contributors responded to those changes with in-depth insights that reflected the complexity of the biosimilars landscape.
Here are the top 5 most-read contributor articles of the year:
5. Biosimilar Nonmedical Switching Must Never Undermine Patient Safety
Gregory Schimizzi, MD, co-convener of the Biologics Prescribers Collaborative and the cofounder of Carolina Arthritis Associates, PA, in Wilmington, North Carolina, wrote that nonmedical switching due to formulary changes by insurers and pharmacy benefit managers puts patient at risk for treatment failures, worsening disease activity, declining physical function, tissue damage, and increased complications. In his article, Schimizzi argued that any formulary-driven nonmedical switching program for biologics and biosimilars should include mandatory provisions for extensive and vigorous pharmacovigilance processes.
4. Treating Biosimilars Equally With Brand Biologics in the Donut Hole
Brian Lehman, MBA, MHA, RPh, explained that the standard Medicare Part D benefit, specifically the coverage gap or “donut hole,” has a significant unintended consequence that results in higher out-of-pocket costs for biosimilars versus competing originator biologics. Last year, he explained, an enrollee would have paid 51% of the total cost for a biosimilar while only paying 40% of the total cost of a brand biologic while in the coverage gap. His article gives a deeper look at the reasons behind this surprising disparity.
3. 340B Changes: What Biosimilar Manufacturers Need to Know
Prior to January 2018, 340B facilities treating Medicare beneficiaries were reimbursed at the average sales price (ASP) of the drug plus 6% (biosimilars at ASP plus 6% of the reference product’s ASP). However, the Medicare Part B Outpatient Prospective Payment System established a new rate for drugs billed by 340B facilities as of 2018 of ASP minus 22.5%. In her article, Amanda Forys, MSPH, a senior director at Xcenda, a part of Amerisource Bergen, explained that biosimilar developers need to use new thinking and develop multipronged strategies to make sure that their products can reach patients in the emerging landscape.
2. Biosimilar Interchangeability: 9 Things to Consider
The topic of interchangeability has been at the forefront of many discussions about the future of US biosimilars, and in her article, Sonia T. Oskouei, PharmD, director of pharmacy program development for biosimilars at Premier, Inc, highlighted 9 key facts that must be kept in mind when discussing these interchangeable products.
1. Assessing the Next Wave of Biosimilars
Now that the FDA has approved 15 biosimilars, it is time to look ahead to the next wave of biosimilar products. Consultants from ZS, a consulting firm that helps companies grow their market share, discussed the ways in which new market dynamics, new players, and new therapeutic areas, will impact the development of biosimilars in the years to come.
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.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.