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Here are the top 5 biosimilar articles for the week of February 3, 2025.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.

Enzeevu (aflibercept-abzv), a biosimilar developed by Sandoz, demonstrated biosimilarity to reference aflibercept (Eylea) in patients with neovascular age-related macular degeneration (nAMD).

Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.

Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.

Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.

Josh Canavan, PharmD, head of pharmacy at RazorMetrics, recommends key educational resources for biosimilars, and emphasizes the extensive research conducted before pharmacy benefit managers (PBMs) add medications, including biosimilars, to their formularies.

January started the year off strong, with several business updates, long-term clinical trial results on multiple biosimilars, and the FDA approval of the third tocilizumab biosimilar.

January 1 marks the launch of the first biosimilar referencing Stelara (ustekinumab) in the US, ushering in a new class of lower-cost medicines for patients with rheumatic and gastrointestinal conditions.

The FDA approved Avtozma, a tocilizumab biosimilar developed by Celltrion, for the treatment of several rheumatic conditions. It is the third biosimilar to reference Actemra (tocilizumab) to be approved for US patients.

Here are the top 5 biosimilar articles for the week of January 27, 2025.

SB5, an adalimumab biosimilar approved in the US, is showing to be safe and effective for patients with psoriasis in the long term, according to a study from the UK and Ireland.

The FDA accepted applications for a golimumab biosimilar, while Samsung Biologics reported record sales, and a Japanese regulatory agency approved a Stelara biosimilar.

Successfully integrating biosimilars into practices requires careful planning and execution, as they impact virtually all aspects of a practice.

Eculizumab biosimilar Elizaria demonstrates long-term safety and efficacy comparable with the reference product Soliris in patients with paroxysmal nocturnal hemoglobinuria (PNH), according to a Russian study that expanded on a previous phase 3 study.

Biosimilar SB17 demonstrated clinical biosimilarity to reference ustekinumab after switching and maintained long-term comparable efficacy and safety up to week 52.

Three players in the biosimilar space have already sparked hope for the new year, with each having big business or regulatory announcements regarding new biosimilar products in Europe and Canada.

A real-world study in adolescent and young adult patients with inflammatory bowel disease (IBD) found no significant differences in lab markers or disease activity between those on Remicade and those switched to biosimilar CT-P13 (Inflectra).

Here are the top 5 biosimilar articles for the week of January 20, 2025.

Biosimilar teriparatide has been shown to be as safe and effective as its reference product for osteoporosis treatment, potentially enabling significant cost savings in Japan’s health care system while addressing persistent misconceptions about biosimilar quality.

When compared with reference aflibercept, a biosimilar ranibizumab was a clinically effective and cost-saving alternative in a study assessing Japanese patients with different subtypes of neovascular age-related macular degeneration (nAMD).

In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.

Sarfaraz K. Niazi, PhD, dives into the role that biosimilar associations and organizations play in promoting biosimilars as well as how their stakeholder demographic and main objectives differ from one another.

The 3 largest pharmacy benefit managers (PBMs) increased many specialty generic drugs prices by hundreds of percent, with some drugs seeing thousands of percent markups, according to the Federal Trade Commission (FTC)’s second interim report on PBM practices.

Functional similarity of the ustekinumab biosimilar ABP 654 (Wezlana) and the reference product (Stelara) was confirmed by a series of in vitro studies, which support the totality of evidence for the biosimliar's FDA approval.

Here are the top 5 biosimilar articles for the week of January 13, 2025.

Biosimilar launches achieve a 53% market share and a 53% reduction in average drug costs after 5 years of biosimilar competition, according to Samsung Bioepis’ most recent market report, showcasing notable pricing trends and market share disparities across therapeutic areas.

A study from Spain found a subcutaneous tocilizumab biosimilar to be cost-effective when treating patients with rheumatoid arthritis (RA) after experiencing improved outcomes.

Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.

The nationwide mandatory switch from Humira (reference adalimumab) to biosimilar adalimumab in Denmark led to no increase in total health care costs over 9 months, with significant cost reductions for those who switched to GP2017 specifically, highlighting the economic feasibility of biosimilar adoption.