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FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job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

Duke Publishes Recommendations for Developing CGT Biosimilars

October 9th 2024

By Skylar Jeremias

Article

Transformative cell and gene therapies (CGT) offer promising treatments for serious conditions, but high costs and complex biologics limit competition, requiring policies that support the development of biosimilars to enhance affordability and patient access.

Biosimilar Rituximab Safe, Effective for SLE After Switching

October 8th 2024

By Cameron Santoro

Article

A study found that switching from rituximab to biosimilar CT-P10 is safe and effective for patients with systemic lupus erythematosus (SLE).

BioRationality—The Evolution of the BPCIA and the Bright Future of Biosimilars in the US

October 7th 2024

By Sarfaraz K. Niazi, PhD

Article

The Biologics Price Competition and Innovation Act (BPCIA) of 2010 initially posed significant barriers to biosimilar development, but regulatory reforms over the years have drastically reduced costs and approval times, with further advancements expected by 2025 that will foster competition and drive down prices.

Biosimilars Policy Roundup for September 2024—Podcast Edition

October 6th 2024

By Skylar Jeremias

Podcast

On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.

Treatment Persistence, Safety After Switching to Infliximab Biosimilars in Canadians With IBD

October 5th 2024

By Deana Ferreri, PhD

Article

A retrospective study of a mandatory nonmedical switch in Canada found no significant differences in rates of treatment persistence, loss of response, or adverse events in patients with inflammatory bowel disease (IBD) on maintenance therapy 1 year post-switch.

The Top 5 Biosimilar Articles for the Week of September 30

October 4th 2024

By Cameron Santoro

Video

Here are the top 5 biosimilar articles for the week of September 30, 2024.

Eye on Pharma: High-Strength Trastuzumab Biosimilar; Originator Coverage Removals; CHMP Aflibercept Opinion

October 3rd 2024

By Skylar Jeremias

Article

The FDA approved a new strength of a trastuzumab biosimilar; UnitedHealth will remove reference adalimumab from some preferred drug lists in favor of biosimilars and Evernorth will offer an interchangeable ustekinumab biosimilar at no cost to patients; Samsung Bioepis received a positive regulatory opinion for its aflibercept biosimilar.

A Promise Unfulfilled: The State of Biosimilars

October 2nd 2024

By Mark Campbell, PharmD

Article

For biosimilars to overcome these entrenched market dynamics, they must not only compete on price but actively work to build a network of support among providers and patients.

Biosimilar Policy Roundup—September 2024

October 1st 2024

By Skylar Jeremias

Article

In September 2024, the FDA approved a new biosimilar for treating retinal conditions, marking a significant development in the biosimilars landscape, coinciding with ongoing legal disputes in the industry and highlighting broader trends in market dynamics and regulatory challenges.

Fourth Ustekinumab Biosimilar, Otulfi, Approved in US

September 30th 2024

By Laura Joszt, MA

Article

Otulfi was approved simultaneously in the European Union. In the US, it will launch in February 2025.