Rheumatology

Phase 3 Study Reports Similar Efficacy Between SB17, Stelara in Psoriasis

October 19th 2024

By Deana Ferreri, PhD

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.

Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review

October 15th 2024

By Skylar Jeremias

Article

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 Lowers Humira Biosimilar Costs, Challenges PBM Pricing

October 15th 2024

By Cameron Santoro

Article

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.

Pharmacokinetic Modeling Proposes Cost-Effective Dosing for Adalimumab, Etanercept Biosimilars

October 12th 2024

By Deana Ferreri, PhD

Article

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.

Samsung Bioepis Report Showcases Adalimumab Biosimilar Growth in Market Share

October 11th 2024

By Skylar Jeremias

Article

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.

Biosimilar Rituximab Safe, Effective for SLE After Switching

October 8th 2024

By Cameron Santoro

Article

A study found that switching from rituximab to biosimilar CT-P10 is safe and effective for patients with systemic lupus erythematosus (SLE).

Eye on Pharma: High-Strength Trastuzumab Biosimilar; Originator Coverage Removals; CHMP Aflibercept Opinion

October 3rd 2024

By Skylar Jeremias

Article

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.

Patient-Reported Outcomes Similar Between Adalimumab-adbm, Reference Product in VOLTAIRE-RA Study

September 28th 2024

By Deana Ferreri, PhD

Article

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.

Eye on Pharma: EC Approved Ustekinumab; Zymfentra Expansion; Biosimilar Policy Briefing

September 26th 2024

By Skylar Jeremias

Article

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.

Expanding Biosimilar Adoption: Insights and Strategies With Dr Sophia Humphreys

September 16th 2024

By Skylar Jeremias

Article

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.