Biosimilars

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.

Projected savings from biosimilars from 2021 to 2025 were $38.4 billion vs conditions as of quarter 4 of 2020 and were driven by new biosimilar entry. Savings were $124.5 billion under an upper-bound scenario.

Despite being the seventh adalimumab biosimilar approved in the United States, there are none on the market yet.

This year the United States only approved 2 biosimilars, but the FDA did grant interchangeable status to the first biosimilar.

In hopes of protecting its lucrative adalimumab (Humira) franchise, AbbVie is mounting a hefty legal defense against Alvotech's adalimumab biosimilar candidate.

Investigators said pathologic complete response was higher with a molecularly selected subgroup of patients with early-stage breast cancer treated with a nonchemotherapy combination that included a trastuzumab biosimilar.

Recent surveys shed light on oncologist and patient perceptions of the switch to biosimilars and patient mental health.

Costs of extending human epidermal growth factor receptor 2 (HER2) therapy for patients with metastatic breast cancer were estimated in a retrospective study.

Investigators hope to duplicate promising phase 2b trial results with an experimental peptide vaccine in a population of nearly 500 patients with human epidermal growth factor receptor 2 breast cancer.

The list of potential adalimumab biosimilars has now lengthened to 10, according to a Cardinal Health summary of these products and their distinguishing features.

Generics and biosimilars are reimbursed differently, causing providers to prefer lower-cost generics and higher-priced biologics, authors of a study and opinion piece contend.

As the cost of oncology drugs increases, there has been a growing pressure to manage oncology drug spend, which some payers have done by establishing preferred therapies, including biosimilars.

The European Medicines Agency (EMA) reports on progress to create a smoother, less wasteful biosimilar development process; and the World Health Organization (WHO) revises its biosimilar development guidelines.