Biosimilars

As biosimilar competition heats up in the United States, payers have more tools at their disposal to manage these agents.

While 2023 is a big year with at least 7 adalimumab biosimilars expected to come to market, 2024 will be even more important because all the products will be on the market and formulary decisions can be made, said Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars at Cardinal Health.

Biosimilar adoption can be accelerated or stymied depending on actions taken by the managed care space, explained Sonia Oskouei, PharmD, vice president, biosimilars, Cardinal Health, during a session at Asembia’s Specialty Pharmacy Summit.

The impact that the adalimumab biosimilars will have in 2023 is going to depend on when they all get to market, said Doug Long, MBA, vice president, industry relations, IQVIA.

Adam Fein, PhD, of Drug Channels Institute, and Doug Long of IQVIA discussed trends in the specialty pharmacy market in the United States.

Scott Gottlieb, MD, and Adam Fein, PhD, discussed potential fallout of the FDA Aduhelm approval and lessons learned from the COVID-19 pandemic.

Not only did a majority of each group say they hadn’t heard of biosimilars, but those who had heard of them had negative perceptions.

Gillian Woollett, MA, Dphil, vice president and head of regulatory strategy and policy at Samsung Bioepis, gives insight into what international markets the United States could look to as examples of good biosimilar adoption.

Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and Winship Cancer Institute, gives insight into how his practice will handle the influx of at least 7 adalimumab biosimilars referencing Humira that are expected to enter the market in 2023.

Increased uptake of biosimilars on par with the utilization rates of filgrastim biosimilars could have saved Medicare Part D $84 million in 2019.

Alymsys from Amneal Pharmaceuticals and mAbxience is the third biosimilar referencing Avastin approved in the United States and the second of 3 biosimilar approvals Amneal expects in 2022.

In patients with intermediate- to high-risk, use of pegfilgrastim biosimilars could optimize management of FN risk.

A trastuzumab biosimilar was found to have similar safety and efficacy with the reference product (Herceptin) in patients with advanced gastric cancer, a population previously excluded from bioequivalence studies for trastuzumab biosimilars.

Chelsee Jensen, PharmD, pharmaceutical formulary manager at the Mayo Clinic, provides her take on why practices will have to continue to stock multiple biosimilars for the same reference product.

Ryan Haumschild, PharmD, MS, MBA, director of pharmacy services at Emory Healthcare and Winship Cancer Institute, explains how payers can play an essential role in improving biosimilar adoption.

Implementing changes in a health system to promote biosimilar adoption is not easy, but by implementing a program, there could be substantial savings.

Patients switched from the originator product maintained their clinical outcomes and remissions status while biologic-naïve patients recorded positive responses and remission outcomes after initiating infliximab-dyyb.

During the recent Association of Community Cancer Centers’ 2022 Annual Meeting & Cancer Center Business Summit, panelists suggested that the laser focus on rebates by pharmacy benefit managers (PBMs) may be hindering uptake of biosimilars, thereby keeping some off of formulary lists.

While filgrastim biosimilars had substantial uptake, there was low uptake of infliximab biosimilars. In addition, there was a lack of price competition.

As the United States awaits market introduction for adalimumab biosimilars in 2023, 2022 is going to be the year of expanding access to biosimilars, according to Julie M. Reed, the new executive director of the Biosimilars Forum.

After years, the biosimilars horizon may be here with valuable opportunities to improve patient outcomes and reduce costs, said Eric Palmer, president and CEO of Evernorth.

A lack of transparency and misaligned incentives had curtailed the adoption of biosimilars in the United States.

Releuko, a filgrastim biosimilar developed by Kashiv Biosciences and Amneal Pharmaceuticals, becomes the third filgrastim biosimilar to be approved by the FDA.

Biocon Biologics announced that it will be acquiring Viatris’ biosimilars portfolio for close to $3 billion.

Julie M. Reed, the new executive director of the Biosimilars Forum, offers her opinion on how interchangeability will impact US biosimilar uptake now that the FDA has given the designation to 2 biosimilars.

Purva Rawal, PhD, senior advisor and chief strategy officer, Center for Medicare and Medicaid Innovation, addressed attendees at the Association for Accessible Medicines' Access! annual meeting, held in Orlando, Florida, February 15-16.

AHIP released a report looking at the price markups for 10 drugs that can be delivered more affordably through specialty pharmacies, including 3 drugs with multiple biosimilars available.

Although the COVID-19 pandemic has led to mass slowdowns in drug approvals and biosimilar launches, 2021 signaled a stronger focus on biosimilars going forward, with new regulatory bills and a crackdown on anticompetitive practices.

Physician and patient resistance to switching from an innovator or reference product to a biosimilar—or from one biosimilar to another—constitutes one of the major barriers to biosimilar adoption, despite the cost savings that can be achieved.

Real-world adoption of bevacizumab-bvzr biosimilar was retrospectively assessed, revealing switching between biosimilars and the reference product and utilization in extrapolated indications and combination regimens.