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FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job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

Learning the Lingo of Biologics and Biosimilars Is Critical

July 31st 2024

By Jeannette Y. Wick, RPh, MBA, FASCP

Article

The number of FDA-approved biologics has exploded, and biosimilars are making their mark.

Singapore Experience Shows Benefits of Value-Driven Strategies in Generating Biosimilar Savings

July 30th 2024

By Skylar Jeremias

Article

Value-driven health care strategies in Singapore’s public institutions have significantly increased biosimilar adoption, leading to reduced treatment costs and substantial savings for the health care system, according to a recent study.

BioRationality: FDA Simplifies Glycan Profiling of mAbs, a Significant Step in Reducing the Cost of Biosimilars

July 29th 2024

By Sarfaraz K. Niazi, PhD

Article

The FDA's new policy on glycan profiling of monoclonal antibodies (Mabs) receives praise and recommendations from Sarfaraz K. Niazi, PhD.

Streamlining Biosimilar Approvals by Balancing Safety, Speed

July 28th 2024

By Cameron Santoro

Video

Ivo Abraham, PhD, RN, University of Arizona Cancer Center, recognizes the importance of stringent safety measures for biosimilar approvals. However, he advocates for utilizing statistical models and placing emphasis on postmarket safety data collection.

CT-P13 Shows Similar Effectiveness, Safety in Biologic-Naive Patients With Crohn Disease

July 27th 2024

By Deana Ferreri, PhD

Article

Celltrion’s infliximab biosimilar CT-P13 demonstrates similar effectiveness and safety to the originator in biologic-naive patients with Crohn disease in a retrospective, real-world study in Japan.

The Top 5 Biosimilar Articles for the Week of July 22

July 26th 2024

By Cameron Santoro

Video

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

Budget Impact Analysis of Biosimilar Natalizumab in the US

July 25th 2024

By Edward Li, PharmD, MPH

Article

Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.

Phase 1 Study Shows Promise for Dulaglutide Biosimilar

July 25th 2024

By Skylar Jeremias

Article

A biosimilar dulaglutide showed similar pharmacokinetic and safety profiles compared with the reference product Trulicity in healthy Chinese participants, according to a phase 1 analysis.

Eye on Pharma: BI Cyltezo Partnership; Europe Ustekinumab Launch; Mexico Biosimilar Approval

July 24th 2024

By Skylar Jeremias

Article

Boehringer Ingelheim (BI) partners with GoodRx to offer its unbranded adalimumab biosimilar to patients at an exclusive low price; a new ustekinumab biosimilar launches in Europe; and Mexican officials approve a bevacizumab biosimilar.

Switching Patterns Highlight Nocebo Effect in European Patients Using Amgevita

July 23rd 2024

By Skylar Jeremias

Article

About half of the patients in a European study who transitioned from reference adalimumab to a biosimilar version stayed on the biosimilar at the 1-year mark. However, researchers warned about a possible nocebo effect resulting in some patients switching back to the originator.