Biosimilars

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.

Sandoz, Lupin, and Biocon Biologics representatives at the Association for Accessible Medicines (AAM) GRx+Biosims conference said that drug price rebates hinder biosimilar competition.

For trastuzumab and bevacizumab, biosimilars now represent a high share of administrations, but payer policies still hinder uptake of these products, the Community Oncology Alliance (COA) reports.

There is now a mad scramble to gain interchangeable status for biosimilars, but the meaning and significance of this appellation haven't yet been worked out for health care consumers or the manufacturing community.

An overview of activities at the FDA to promote the use of biosimilars was presented by Jacqueline Corrigan-Curay, JD, MD, principal deputy center director for the Center for Drug Evaluation and Research (CDER) at the FDA.

Pharmacy experts from IPD Analytics explained the potential for authorized biologics, which would compete, potentially on the same price footing, with biosimilars.

There are a number of trastuzumab biosimilars available, but so far there have not been any patient characteristics that have played a role in which ones are prescribed, said Cate Lockhart, PhD, PharmD, MS, program, director, Biologics and Biosimilars Collective Intelligence Consortium.

Education is needed for both patients and pharmacists to ensure appropriate understanding, investigators reported at the Academy of Managed Care Pharmacy (AMCP) Nexus 2021 meeting.

Adalimumab biosimilar AVT02 exhibited comparative efficacy, safety, tolerability, and immunogenicity to the reference drug Humira in patients with moderate-to-severe chronic plaque psoriasis.