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.
Budget Impact Analysis of Biosimilar Natalizumab in the US
Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Hesitancy in MENA Nations to Adopt WHO Biosimilar Guidelines Hinders Market Development
July 17th 2024The World Health Organization’s (WHO) new guidelines for biosimilar approvals aim to save time and money for manufacturers in the Middle East and North Africa (MENA), but hesitancy among nations to adopt the guidelines is stifling market development of biosimilars.
BioRationality: Time to Get Rid of PBMs if Biosimilars Are to Succeed
July 15th 2024Sarfaraz K. Niazi, PhD, discusses the challenges with pharmacy benefit managers (PBMs) that plague the biosimilar industry and new legislation that attempts to reform their practices and encourage biosimilar adoption.