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FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job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

The Top 5 Most-Read Ophthalmology Stories of 2023

December 23rd 2023

By Skylar Jeremias

Article

The top 5 most-read ophthalmology stories of 2023 concerned clinical results, approvals, and launches for ranibizumab and aflibercept biosimilars.

The Top 5 Biosimilar Articles for the Week of December 18

December 22nd 2023

By Cameron Santoro

Video

Here are the top 5 biosimilar articles for the week of December 18th, 2023.

Assays Reveal Equivalence Between Adalimumab-aqvh and Humira

December 21st 2023

By Cameron Santoro

Article

Comprehensive assay research concluded similar structures, functions, and stability between reference adalimumab (Humira) and adalimumab-aqvh.

Q&A: Dr Kimberly Maxfield Explains How BsUFA III Will Advance the US Biosimilar Industry

December 20th 2023

By Skylar Jeremias

Article

At AMCP Nexus, Kimberly Maxfield, PhD, pharmacologist at the FDA, delved into how the third reauthorization of the Biosimilar User Fee Act (BsUFA III) will shape the American biosimilar market and improve development efficiency over the next few years.

FDA Approves Avzivi, the Fifth Biosimilar to Avastin

December 19th 2023

By Skylar Jeremias

Article

The FDA approved Bio-Thera Solutions’ Avzivi (bevacizumab-tnjn), the fifth biosimilar referencing Avastin (bevacizumab) to be approved in the United States.

BioRationality: In FDA We Trust—A Commentary on FDA Efforts to Educate Biosimilar Stakeholders

December 18th 2023

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, offers his perspective on FDA biosimilar education efforts and the role these efforts and stakeholder perspectives play in uplifting—or undermining—biosimilar adoption.

The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur

December 17th 2023

By Skylar Jeremias

Podcast

On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).

Enoxaparin Biosimilar Shows Similar Efficacy to Originator in Preventing Postoperative Subclinical Thrombosis

December 16th 2023

By Deana Ferreri, PhD

Article

The biosimilar Enoxa (enoxaparin), marketed in Tunisia, demonstrated equivalence in preventing subclinical postoperative thrombotic events in patients with digestive cancers to Sanofi’s Lovenox, in a randomized controlled trial.

The Top 5 Biosimilar Articles for the Week of December 11

December 15th 2023

By Cameron Santoro

Video

Here are the top 5 biosimilar articles for the week of December 11, 2023.

SABCS Posters Evaluate Real-World Outcomes Associated With Ogivri

December 14th 2023

By Skylar Jeremias

Article

Two Taiwanese posters presented at the San Antonio Breast Cancer Symposium (SABCS) 2023 annual meeting evaluated the real-world implications of using trastuzumab biosimilars, particularly Ogivri (trastuzumab-dkst) in patients with HER2-postive breast cancer.