Gastroenterology

FDA approval clears interchangeable golimumab biosimilars for rheumatoid arthritis and ulcerative colitis, promising lower-cost TNF therapy.

Explore this year's advancements in gastroenterology biosimilars, highlighting key FDA approvals and market dynamics impacting IBD treatment options.

Patients with Crohn disease report high satisfaction and minimal discomfort using the citrate-free biosimilar CT-P17, enhancing adherence to treatment.

New findings explore the adalimumab biosimilar landscape, focusing on formulation, devices, and patient support programs that enhance treatment experiences.

A study reveals that switching from Humira to Amgevita for IBD maintains disease control and offers significant cost savings.

A recent Japanese study confirms that switching from originator infliximab to biosimilars maintains remission in patients who have rheumatoid arthritis, enhancing treatment accessibility.

Explore groundbreaking developments in biosimilars, including patent lawsuits, new ustekinumab launches, and innovative access strategies for patients.

CT-P6 demonstrates strong efficacy and safety in HER2-positive advanced gastric cancer, achieving an 82% disease control rate in real-world settings.

Long-term data from the SAME study confirm that switching to infliximab biosimilars is safe and effective for patients with inflammatory bowel disease (IBD).

The MEGA-J study reveals CT-P13's long-term safety and effectiveness in treating inflammatory bowel disease and rheumatoid arthritis, with minimal adverse reactions.

About 13% of patients who switch from Humira to an adalimumab biosimilar switch back to the originator, according to research from Truveta. However, the presented data may not tell the full story.

Pediatric infliximab biosimilar use has risen significantly, reflecting evolving treatment patterns in inflammatory bowel disease (IBD) among children and young adults.

A real-world study reveals that pediatric patients with IBD achieve high remission rates and cost savings using adalimumab biosimilars over time.

Alvotech and Dr. Reddy's partner to develop a Keytruda biosimilar, a German court bans Humira biosimilar over patent dispute, and Samsung Bioepis enters a strategic agreement with NIPRO Corporation in Japan.

Patients with inflammatory bowel disease (IBD) show high acceptance of adalimumab biosimilars, achieving positive outcomes and clinical remission after switching.

New research highlights the efficacy and high patient satisfaction of adalimumab biosimilars in treating inflammatory diseases.

Real-world study reveals comparable effectiveness of bevacizumab biosimilars and Avastin in metastatic colorectal cancer (CRC), boosting clinician confidence.

The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.

Starjemza gains FDA approval as the eighth ustekinumab biosimilar, enhancing treatment options for rheumatic and gastrointestinal conditions.

There's a need for early anti-tumor necrosis factor (TNF) therapy in inflammatory bowel disease (IBD), with new data showing that biosimilars can address cost barriers and enhance patient access and outcomes.

Monthly savings from fully converting Medicare patients with metastatic colorectal cancer (CRC) and non-squamous metastatic non-small cell lung cancer (NSCLC) from reference bevacizumab to bevacizumab-bvzr could fund 13,887 and 8,959 additional patient-months of treatment, respectively, according to a cost-effectiveness study.

A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.

A plain language summary for patients explains there were no differences in safety outcomes between adalimumab-adbm and the originator in a pooled analysis of the VOLTAIRE clinical trials.

Biosimilars are proving to be a game-changing solution in the fight against inflammatory bowel disease (IBD), offering a cost-effective alternative to biologics with similar efficacy and safety, while innovative drug delivery systems promise to further enhance treatment outcomes and accessibility for millions worldwide.

Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.

A retrospective study from a single inflammatory bowel disease (IBD) center in Greece reported that from 2018 to 2022, the use of biologics increased by 28% yearly, and the proportion of patients using biosimilars grew from 33% to 67%.

During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.

High adherence rates, comparable clinical effectiveness, and cost savings have marked the early adoption of adalimumab biosimilars in the US, particularly in formulary-driven transitions, as shown in 2 retrospective studies presented at the Academy of Managed Care Pharmacy annual meeting (AMCP 2025).