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FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job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

What Types of Patents Are to Blame for Biosimilar Market Delays?

January 29th 2024

By Skylar Jeremias

Article

Although manufacturing patents tend to be the most common type of patent referenced in litigation regarding biosimilar development, other patents actually have a greater impact on delays for biosimilar market launches.

Biosimilar Adoption Policy Proves Successful After 8 Years in a UK Tertiary Hospital

January 28th 2024

By Skylar Jeremias

Article

During a 6-year follow-up period, a UK tertiary hospital observed greater biosimilar adoption than the English average after it implemented a new policy that prioritizes best-value biologics, including biosimilars, for new-start patients and those already treated with originators.

Biosimilars Improve Access to Biologic Therapies, JAK Inhibitors for Patients With RMDs

January 26th 2024

By Cameron Santoro

Article

A 10-year analysis in Poland found that the introduction of biosimilar drugs significantly increased access to biologic therapies and Janus kinase (JAK) inhibitors for patients with rheumatic musculoskeletal diseases (RMDs), while also reducing treatment costs.

The Top 5 Biosimilar Articles for the Week of January 22

January 26th 2024

By Cameron Santoro

Video

Here are the top 5 biosimilar articles for the week of January 22, 2024.

Eye on Pharma: Eylea Biosimilar Violation; New FDA Labeling Guidance; Alvotech Reinspection

January 25th 2024

By Skylar Jeremias

Article

A Korean health agency issued Samsung Bioepis an administrative penalty related to its biosimilar referencing Eylea (aflibercept); the FDA updates its labeling recommendations for interchangeable biosimilars; Alvotech receives another Form 483 after the FDA reinspected its Iceland-based manufacturing facility.

Bevacizumab Biosimilar MB02 Demonstrates Bioequivalence in Key Safety Parameters With Avastin

January 24th 2024

By Cameron Santoro

Article

A combined analysis of 3 studies found that the drug MB02 is comparable to reference bevacizumab (Avastin) in terms of its pharmacokinetics, safety, and immunogenicity.

Report: Varied Biosimilar Uptake Speeds Pose Missed Opportunities for Cost Savings

January 23rd 2024

By Skylar Jeremias

Article

Samsung Bioepis’ Biosimilar Market Report for the first quarter of 2024 chronicles some major market trends, including which treatment spaces have quicker uptake than others, highlighting missed opportunities for savings as well as the 1-year experience of adalimumab biosimilar competition in the US.

BioRationality: It Takes 4 to Tango—How US Entities Can Make Biosimilars Accessible

January 22nd 2024

By Sarfaraz K. Niazi, PhD

Article

The FDA, Congress, biologic developers, and associations dedicated to evaluating the US biopharmaceutical space will need to work together to overcome challenges to biosimilar accessibility, says Sarfaraz K. Niazi, PhD, in his new column.

Greater Biosimilar Uptake Found in Medicare Advantage Than Traditional Medicare

January 21st 2024

By Cameron Santoro

Article

Biosimilar uptake was greater in Medicare Advantage plans when compared with traditional Medicare plans.

Postapproval Pharmacovigilance Review Confirms Comparable Safety Between Sandoz Biosimilars, Originators

January 20th 2024

By Deana Ferreri, PhD

Article

Authors of a review of available postapproval pharmacovigilance data assessing 8 Sandoz biosimilars concluded that these biosimilars “can be used as safely as their respective reference biologics.”