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FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job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

Revolutionizing Biopharmaceuticals: The EU's Biosimilar Success and Remaining Challenges

October 16th 2024

By Skylar Jeremias

Article

The European Union's (EU) approach to biosimilars has revolutionized the biopharmaceutical market by driving innovation, lowering costs, and increasing adoption; however, there remains a need for more education, real-world evidence, and efforts to address challenges to enhance patient access and affordability.

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.

IQVIA Webinar: Enhancing Regulatory Strategies for Biosimilars and Generics

October 14th 2024

By Skylar Jeremias

Article

During a recent webinar, experts discussed critical regulatory aspects for generics and biosimilars, highlighting strategies for navigating complex approval processes, the importance of local market understanding, and the role of technology in enhancing submission efficiency.

From Skepticism to Success: Insights Into Biosimilar Market Acceptance

October 13th 2024

By Cameron Santoro

Video

Ivo Abraham, PhD, RN, director of the Center for Health Outcomes and PharmacoEconomic Research at the University of Arizona Cancer Center, discusses the potential of biosimilars and challenges in the US, emphasizing partnerships for market growth.

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.

FDA Approves Imuldosa, a Biosimilar to Stelara

October 11th 2024

By Skylar Jeremias

Article

Imuldosa (ustekinumab-srlf) is the fifth ustekinumab biosimilar referencing Stelara to receive regulatory approval in the US.

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.

The Top 5 Biosimilar Articles for the Week of October 7

October 11th 2024

By Cameron Santoro

Video

Here are the top 5 biosimilar articles for the week of October 7, 2024.

Sandoz Report: A Unified Approach to Overcoming Drug Shortages

October 10th 2024

By Skylar Jeremias

Article

A report from Sandoz emphasizes the need for collaboration among stakeholders to eliminate drug shortages impacting over 90% of hospital systems in the US, recommending policy changes and actions to address the ongoing issue, which has caused treatment delays and increased costs.