Biosimilars

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.

Cardinal Health's report, “2022 Biosimilars Report: The U.S. Journey and Path Ahead,” outlines how biosimilars will move beyond their comfort zones in oncology and rheumatology and more boldly into therapeutic areas such as ophthalmology and diabetes care.

Kathy Oubre, MS, chief operating officer of Pontchartrain Cancer Center, talks about how biosimilars have been able to help patients avoid financial toxicity related to oncology care costs.

The Biosimilars Initiative in British Columbia, Canada, mandated patients with certain conditions on the province’s prescription coverage plan to switch from originator etanercept to a biosimilar.

Biogen is selling its stake in the biosimilar joint venture to Samsung Bioepis for up to $2.3 billion after first investing in 2012.

Payer intervention, lack of patient savings, and confusion surrounding interchangeability are some of the many barriers standing in the way of US biosimilar uptake, with our group of panelists calling for big changes.

Researchers have found that most US patent infringement cases against biosimilar manufacturers cover patents filed over a decade after the originator product's FDA approval, leading to limits on competition among biologic drugs.

The trastuzumab biosimilar Herzuma was shown to have similar clinical efficacy and safety to the reference product in patients with HER2-positive advanced gastric cancer.

Compared with the European Union, biosimilar use in the United States lags, and the US government, health systems, and medical associations all have a role to play.

More biobetter drugs may be on the horizon, with an opportunity to snatch market share from reference products, and several biosimilars are under development for ophthalmic conditions, authors of a review concluded.

At least 8 biosimilars were approved in Canada over the past 12 months, as policy makers made a strong push for biosimilar acceptance, which led to a change in prescribing patterns.