Gastroenterology

FDA Approves Steqeyma: The Seventh Stelara Biosimilar

December 18th 2024

By Skylar Jeremias

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

Stable Patient Satisfaction Found After Switching From the Humira or Biosimilar CT-P17

December 14th 2024

By Deana Ferreri, PhD

Article

A real-world study in France found patient satisfaction was stable after switching from either the reference product or a low-concentration adalimumab biosimilar to the adalimumab biosimilar CT-P17, a high-concentration, citrate-free formulation.

Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration

December 10th 2024

By Skylar Jeremias

Article

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.

Similar Persistence Rates Between Adalimumab New Starts, Switched Patients

December 7th 2024

By Deana Ferreri, PhD

Article

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.

Perceptions of Biosimilar Switching Among Veterans With IBD

December 2nd 2024

By Deana Ferreri, PhD

Article

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.

Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition

December 1st 2024

By Skylar Jeremias

Podcast

On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.

Biosimilars Gastroenterology Roundup: November 2024

November 30th 2024

By Skylar Jeremias

Article

In November 2024, Skyrizi surpassed Humira as AbbVie's top seller; calls for PBM transparency and biosimilar access reforms grew; Celltrion expanded its portfolio; and Global Biosimilars Week focused on improving affordability and equity.

Achieving PFS in Advanced Gastric Cancer With HLX02 Biosimilar, Chemotherapy

November 23rd 2024

By Deana Ferreri, PhD

Article

In a phase 2 study, the addition of HLX22, an anti-HER2 antibody, to HLX02 biosimilar and XELOX (oxaliplatin and capecitabine) chemotherapy extended progression-free survival (PFS) in untreated HER2-positive advanced gastric cancer patients.

Subcutaneous Infliximab CT-P13 Superior to Placebo as Maintenance Therapy for IBD

November 16th 2024

By Deana Ferreri, PhD

Article

In 2 randomized controlled trials of maintenance therapy for inflammatory bowel disease (IBD), the subcutaneous formulation of the infliximab biosimilar CT-P13 demonstrated superiority to placebo in patients with Crohn disease and ulcerative colitis.

Challenges, Obstacles, and Future Directions for Anti-TNF Biosimilars in IBD

November 9th 2024

By Deana Ferreri, PhD

Article

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.