The Top 5 Most-Read Gastroenterology Stories of 2023

The top 5 most-read gastroenterology stories of 2023 examined clinical data for adalimumab biosimilars, some Canadian regulatory news, and inflation rate predictions from Vizient.

Here are the most-read gastroenterology stories of 2023.

5. Vizient Report Predicts Over 3% Inflation Rate for Biologics

In Vizient's Pharmacy Market Outlook, a 3.78% inflation in drug prices was predicted, influenced by geopolitical factors and heightened demand during the COVID-19 pandemic. Biologics and injectables experienced higher inflation rates at 3.05% and 3.26%. The report highlighted the entry of the first adalimumab biosimilar (Amjevita) and foresaw preferences for specific adalimumab biosimilars. Vizient recommended collaborative agreements for smoother transitions to biosimilars and addressed challenges like white bagging, urging engagement within pharmacy organizations.

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4. Canada Approves High-Concentration Humira Biosimilar

Samsung Bioepis received Canadian approval for Hadlima HC, its high-concentration Humira biosimilar. The approval, 4 years after the low-concentration version, covers both formulations for treating various rheumatic conditions. Health Canada approved the high-concentration version based on a phase 1 trial, citing equivalent pharmacokinetics, safety, and tolerability compared with the low-concentration one. Samsung Bioepis also provided updates on biosimilars for Soliris, Prolia/Xgeva, and Stelara, with positive results reported for SB12 (eculizumab biosimilar), SB17 (ustekinumab biosimilar), and SB16 (denosumab biosimilar) in phase 3 studies.

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3. Higher Risk of Discontinuation During Biosimilar Switching Found Among Women

During the transition from reference adalimumab, the PROPER study by BioDrugs found that candidate predictors weren't linked to SB5 discontinuation, except for female sex in rheumatoid arthritis, axial spondyloarthritis, and Crohn disease. Of the 955 patients with inflammatory diseases, 75.6% continued SB5 at week 48. Disease activity remained stable, and no new safety signals emerged, supporting the feasibility of transitioning to biosimilars. The study recommends special consideration for female patients considering switching.

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2. Study Confirms Safety and Efficacy of Adalimumab Biosimilar HS016 in IBD

A Chinese study confirmed the safety and efficacy of HS016 (adalimumab biosimilar) for inflammatory bowel disease (IBD). Involving 91 patients at Xijing Hospital, the study found that HS016 showed clinical response and remission with a favorable safety profile. Therapeutic drug monitoring (TDM) underscored HS016's cost-effectiveness, broadening treatment options for Chinese patients with IBD. The research highlights TDM's role in treatment optimization and anticipates an increased availability of biological agents for IBD therapy.

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1. Research Confirms Long-Term Stability of Adalimumab Biosimilar Candidate TUR01

TUR01, an adalimumab biosimilar by Turgut İlaçları, displayed sustained stability in both substance and product under various temperatures, meeting guidelines. Stored in specific containers, the drug substance remained stable for 18 months at or below –65°C and 5°C. The drug product maintained stability for 24 months refrigerated and 2 months at room temperature. The study offers crucial insights for biosimilar storage conditions.

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