Danish Registry Analysis Finds Consistent Safety After Switching to Infliximab Biosimilar GP1111

February 03, 2026

New Danish registry data confirm the safety of switching to infliximab biosimilars, showing low rates of serious adverse events in patients with inflammatory arthritis.

Q&A With Chelsee Jensen, PharmD: FDA Policy Shifts, Biosimilar Development Hurdles, and Market Access in 2026

February 02, 2026

Early Evidence Supports KM118 as a Biosimilar to Reference Pertuzumab

January 28, 2026

Milestone Approvals, Evolving PBM Models May Redefine the 2026 Biosimilar Landscape

January 27, 2026

FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job

January 26, 2026

Cost-Benefits, Efficacy of Biosimilar Ranibizumab vs Aflibercept for nAMD in Japan

January 22nd 2025

By Skylar Jeremias

Article

When compared with reference aflibercept, a biosimilar ranibizumab was a clinically effective and cost-saving alternative in a study assessing Japanese patients with different subtypes of neovascular age-related macular degeneration (nAMD).

A Banner Year for Biosimilars: The 19 FDA Approvals From 2024

January 21st 2025

By Skylar Jeremias

Article

In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.

BioRationality: Biosimilar Associations and Stakeholders Representing Biosimilars

January 20th 2025

By Skylar Jeremias

Article

Sarfaraz K. Niazi, PhD, dives into the role that biosimilar associations and organizations play in promoting biosimilars as well as how their stakeholder demographic and main objectives differ from one another.

FTC Releases Second Report on PBMs Meddling in Generic Drug Markets

January 19th 2025

By Skylar Jeremias

Article

The 3 largest pharmacy benefit managers (PBMs) increased many specialty generic drugs prices by hundreds of percent, with some drugs seeing thousands of percent markups, according to the Federal Trade Commission (FTC)’s second interim report on PBM practices.

Functional Similarity Between Ustekinumab Biosimilar ABP 654, Stelara in Crohn Disease

January 18th 2025

By Deana Ferreri, PhD

Article

Functional similarity of the ustekinumab biosimilar ABP 654 (Wezlana) and the reference product (Stelara) was confirmed by a series of in vitro studies, which support the totality of evidence for the biosimliar's FDA approval.

The Top 5 Biosimilar Articles for the Week of January 13

January 17th 2025

By Cameron Santoro

Video

Here are the top 5 biosimilar articles for the week of January 13, 2025.

Biosimilars Drive Cost Savings and Achieve 53% Market Share Across Treatment Areas

January 16th 2025

By Skylar Jeremias

Article

Biosimilar launches achieve a 53% market share and a 53% reduction in average drug costs after 5 years of biosimilar competition, according to Samsung Bioepis’ most recent market report, showcasing notable pricing trends and market share disparities across therapeutic areas.

Biosimilar Tocilizumab Cost-Effective for Treatment of Rheumatoid Arthritis in Spain

January 16th 2025

By Cameron Santoro

Article

A study from Spain found a subcutaneous tocilizumab biosimilar to be cost-effective when treating patients with rheumatoid arthritis (RA) after experiencing improved outcomes.

Improving Biosimilar Access Through Global Regulatory Convergence

January 15th 2025

By Skylar Jeremias

Article

Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.

Cost-Efficiency in Action: Denmark's Transition to Biosimilar Adalimumab

January 14th 2025

By Skylar Jeremias

Article

The nationwide mandatory switch from Humira (reference adalimumab) to biosimilar adalimumab in Denmark led to no increase in total health care costs over 9 months, with significant cost reductions for those who switched to GP2017 specifically, highlighting the economic feasibility of biosimilar adoption.