Immunology

The Department of Veterans Affairs (VA) saved $67 million in 2023 through its strong adoption of biosimilars to curb the high costs of biologic therapies to treat chronic disease.

2025 marks a pivotal year for biosimilars with Amgen's Wezlana leading ustekinumab biosimilar launches, potentially driving savings and access, as highlighted by Dracey Poore, MS, of Cardinal Health.

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.

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.

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.

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.

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.

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.

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.

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.

The FDA approved Celltrion's Steqeyma (ustekinumab-stba), making it the seventh biosimilar slated to compete against blockbuster Stelara (reference ustekinumab) in 2025.

Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.

A French real-world study found that the adalimumab biosimilar SB5 was effective in treating rheumatic or gastrointestinal immune-mediated inflammatory diseases, showing no loss of disease control in switched patients and similar persistence rates between naive and switched groups.

The study highlights the safety, efficacy, and cost benefits of infliximab biosimilars in managing pediatric noninfectious uveitis, showing fewer disease flares and reduced costs compared with reference infliximab, as well as the influence of insurance mandates on treatment decisions.

Veterans with inflammatory bowel disease (IBD) prioritize shared decision-making, transparency, and individualized care in biosimilar switching, favoring delayed switching for severe cases and greater patient control.

For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.

Celltrion plans to commercialize 22 biosimilars by 2030, expanding its global presence with robust sales growth driven by core biosimilars and new launches like subcutaneous infliximab.

Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.

Panelists emphasized the need for transparency and policy reforms in pharmacy benefit management (PBM) to improve accessibility, affordability, and fair competition for adalimumab biosimilars.

A phase 3, 28-week comparative clinical trial in patients with moderate to severe plaque psoriasis confirmed similarity of the proposed ustekinumab biosimilar SB17 (Samsung Bioepis) to the reference product (Stelara) in efficacy, safety, pharmacokinetics, and immunogenicity.

Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.

Blue Shield of California will offer an adalimumab biosimilar at a price that is 75% less than the reference product Humira for the monthly dose.

A UK cohort study used drug concentration samples from rheumatoid arthritis patients starting the adalimumab biosimilar Amgevita and the etanercept biosimilar Benepali to simulate drug levels under standard and alternate dosing schedules, suggesting that personalized dosing could reduce costs while potentially increasing efficacy.

Adalimumab biosimilars have seen a significant increase in market share, from 2% in early 2024 to 22%, as payers and pharmacy benefit managers begin to prioritize these biosimilars over the reference product, Humira.

A retrospective study of a mandatory nonmedical switch in Canada found no significant differences in rates of treatment persistence, loss of response, or adverse events in patients with inflammatory bowel disease (IBD) on maintenance therapy 1 year post-switch.

The FDA approved a new strength of a trastuzumab biosimilar; UnitedHealth will remove reference adalimumab from some preferred drug lists in favor of biosimilars and Evernorth will offer an interchangeable ustekinumab biosimilar at no cost to patients; Samsung Bioepis received a positive regulatory opinion for its aflibercept biosimilar.

A summary of research written by Vibeke Strand, MD, clinical professor in division of immunology/rheumatology at Stanford University School of Medicine, gave an overview of patient-reported outcomes (PROs) in the VOLTAIRE-RA trial.

The European Commission (EC) approved Celltrion's ustekinumab biosimilar for chronic inflammatory diseases, Celltrion expanded access to Zymfentra (subcutaneous infliximab-dyyb) through partnerships with Cigna and Express Scripts, and the Association for Accessible Medicines held a policy briefing addressing barriers to biosimilar adoption.

An observational study assessing patient satisfaction with adalimumab for inflammatory bowel disease (IBD) reported a high level of satisfaction with all adalimumab product, including biosimilars.