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.
Eye on Pharma: Bevacizumab Update; Samsung Bioepis, J&J Settlement; Another EU Trastuzumab
December 6th 2023Outlook Therapeutics provides an update on the development of its bevacizumab candidate for age-related macular degeneration; Samsung Bioepis settles with Johnson & Johnson (J&J) over its ustekinumab biosimilar candidate; and the European Union gains another trastuzumab biosimilar.
Biosimilar Business Roundup for October 2023—Podcast Edition
November 5th 2023On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.
Study Documents HCPs’ Experiences of a Mandatory Switch to Inform Future Transitions
December 2nd 2023A survey explores the experiences of health care providers (HCP) in New Zealand throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in 2022.
Biosimilars Business Roundup For August 2023—Podcast Edition
September 5th 2023On this episode, we’re giving an overview of some of the biggest stories in the business space regarding biosimilars, like the approval of the first neurology biosimilar, growth projections from company quarterly expense reports, and some analyses about the health of the market.
CVS Caremark Switches Up Biosimilar Coverage in 2024
November 27th 2023As new biosimilars are added to CVS Caremark’s standard formulary, others are removed. One notable change is with the Humira biosimilars: the pharmacy benefit manager has removed Amjevita in favor of Hyrimoz and an unbranded biosimilar.