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FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job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

Dr Stephen Hanauer Welcomes Adalimumab Biosimilars to the Gastroenterology Space

October 8th 2023

By Skylar Jeremias

Video

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, explained the initial experience gastroenterologists have had with anti–tumor necrosis factor biosimilars and how new adalimumab biosimilars will impact the space.

The Promise of Biosimilars Is Within Reach for Health Systems

October 7th 2023

By Jim Lichauer, PharmD, BCPS, FASHP

Article

A collaborative exercise with 16 health care organizations nets millions in savings.

The Top 5 Biosimilar Articles for the Week of October 2

October 6th 2023

By Justina Petrullo

Video

Here are the top 5 biosimilar articles for the week of October 2, 2023.

Abrilada Approved as Second Interchangeable Humira Biosimilar

October 5th 2023

By Skylar Jeremias

Article

Pfizer’s Abrilada (adalimumab-afzb) became the second biosimilar referencing Humira (adalimumab) to receive an interchangeable designation. The new label is intended to expand patient access to biosimilars.

FDA Approves First Tocilizumab Biosimilar

October 5th 2023

By Skylar Jeremias

Article

Tofidence, a tocilizumab biosimilar developed by Biogen, will be used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

Webinar: Experts Discuss Avenues to Improve Biosimilar Development Efficiency

October 4th 2023

By Skylar Jeremias

Article

A recent webinar featured an in-depth discussion on the impacts that updated guidelines, a reduction in clinical efficacy testing, and biomarker analyses can have on the efficiency of biosimilar development.

BioRationality: Calling on Developers to Help Address Remaining Biosimilar Issues

October 3rd 2023

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, summarized the citizen petitions he's filed to the FDA as well as changes he believes are needed to propel the biosimilar industry into the future, including calling on biosimilar manufacturers to help.

Biosimilars Regulatory Roundup: September 2023

October 2nd 2023

By Skylar Jeremias

Article

September was graced with several regulatory updates from around the world, including some European and Japanese approvals, as well as the FDA’s 2-day workshop on the current science behind clinical efficacy testing for biosimilars and streamlining biosimilar development.

Biosimilars Regulatory Roundup for September 2023—Podcast Edition

October 1st 2023

By Justina Petrullo

Podcast

On this episode, we discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.

Common Patient Questions About Insulin Biosimilars Pertain to Classification

September 30th 2023

By Camlyn Masuda, PharmD, BCACP, CDCES

Article

Nuances in classification for insulin biosimilars can lead to frequent areas of confusion, according to 2 pharmacists.