Gastroenterology

A review article on tumor necrosis factor (TNF)-α inhibitors in inflammatory bowel disease (IBD) outlined current use of anti-TNF originators and biosimilars, their efficacy and safety, the benefits and challenges of biosimilars, and the future of biosimilars in IBD.

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 study of the Veterans Health Administration detailed their experience with infliximab biosimilars in a population of patients with inflammatory bowel disease (IBD) who were naive to infliximab.

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.

Sophia Humphreys, PharmD, MHA, BCBBS, director of system formulary management at Sutter Health, discusses the challenges of expanding biosimilars into new therapeutic areas and highlights the role of education, competitive pricing, and integrated delivery networks in improving adoption and market growth.

German biosimilar manufacturer STADA Arzneimittel reported a 9% revenue increase in the first half of 2024, with over €2 billion in sales, driven in part by biosimilar successes and new product launches.

A real-world study of the biosimilar infliximab-dyyb (CT-P13; Inflectra) in rheumatoid arthritis (RA) reported the majority of patients who initiated CT-P13 switched from the reference product (Remicade) or another biologic or targeted synthetic disease-modifying antirheumatic drug.

Switching children with juvenile idiopathic arthritis (JIA) from anti–tumor necrosis factor originators to biosimilars showed similar disease activity and drug persistence, with good tolerability, supporting the safety and effectiveness of non-medical switching.

Researchers surveyed clinicians from 63 countries and found that adalimumab and infliximab biosimilars, primarily chosen for their lower cost, are widely available and have improved access to biologic treatment in inflammatory bowel disease (IBD).

Celltrion's adalimumab-aaty biosimilar is now accessible for all Costco members, while Amgen sues Samsung Bioepis over the latter’s denosumab biosimilar candidate, and GlycoNex progresses its denosumab biosimilar SPD8 to phase 3 trials.

CMS announced negotiated prices for 10 drugs under the Inflation Reduction Act (IRA), sparking mixed reactions, with concerns that including drugs facing imminent biosimilar competition could hinder market access to lower-cost alternatives.

An analysis of subcutaneous biosimilar and originator tumor necrosis factor (TNF) inhibitors for rheumatic diseases found no significant differences in survival or discontinuation rates due to inefficacy or adverse events, with biosimilars showing lower overall discontinuation rates and higher retention rates.

Manitoba’s new policy means that all 10 Canadian provinces now have an initiative to boost biosimilar adoption and savings by transitioning patients on reference agents to biosimilar options.

Products in line to face biosimilar competition are projected to increase their list prices in advance, according to Vizient’s Pharmacy Market Outlook Report for Summer 2024.

Celltrion’s infliximab biosimilar CT-P13 demonstrates similar effectiveness and safety to the originator in biologic-naive patients with Crohn disease in a retrospective, real-world study in Japan.

Boehringer Ingelheim (BI) partners with GoodRx to offer its unbranded adalimumab biosimilar to patients at an exclusive low price; a new ustekinumab biosimilar launches in Europe; and Mexican officials approve a bevacizumab biosimilar.

Although biosimilars reduce drug purchasing costs for hospitals, it’s unclear whether those savings might be offset by increased health resource utilization following a non-medical switching initiative.