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FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job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

Patient Surveys Provide Insight Into Real-World Adalimumab Biosimilar Use in IBD

September 19th 2023

By Skylar Jeremias

Article

A study evaluating the real-world impact of treating patients with inflammatory bowel disease (IBD) with an adalimumab biosimilar found that providing patient questionnaires early can be useful for identifying those at a higher risk of treatment discontinuation.

Part 2: FDA Workshop Shares Manufacturer Perspective on the Value of Clinical Efficacy Testing

September 18th 2023

By Skylar Jeremias

Article

Although removing the requirement for clinical efficacy testing for biosimilar approval would reduce development costs of biosimilars, representatives from several biosimilar manufacturers argued in the second day of the FDA’s development workshop that clinical outcomes will not be affected.

Dr Fran Gregory Sizes Up the US Adalimumab Market: Will Biosimilars See Success?

September 17th 2023

By Skylar Jeremias

Podcast

On this episode of Not So Different, Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, analyzes the adalimumab market so far in the United States and provides insight into how the market needs to adapt to accept these products and ensure lower drug costs for patients.

The Top 5 Biosimilar Articles for the Week of September 11

September 15th 2023

By Justina Petrullo

Video

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

Biologic Availability Contributes to Medicare Part B Drug Expenditure Growth

September 14th 2023

By Justina Petrullo

Article

Growing use of innovator biologics, including those with biosimilar competition, has led to increased Medicare Part B drug expenditures, with the trend unlikely to stop.

Part 1: FDA Workshop Highlights Global Regulatory View on Biosimilar Development

September 13th 2023

By Skylar Jeremias

Article

An FDA workshop featuring regulators from around the world provided the regulatory perspective on how each government determines whether a biosimilar is clinically equivalent to their reference product, highlighting the science behind their development guidelines.

AAM Report: Generics and Biosimilars Generate $408 Billion in 2022

September 12th 2023

By Skylar Jeremias

Article

A report from the Association for Accessible Medicines (AAM) highlighted the value of biosimilars and generics, revealing that lower-cost versions of originator products accumulated $408 billion for the US health care system in 2022.

Link Between Antidrug Antibodies and bDMARDs Nonresponse in Patients With RA

September 11th 2023

By Justina Petrullo

Article

Study results suggest an association between antidrug antibodies and nonresponse to biologic disease-modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA).

Fran Gregory Weighs In on the Value of Interchangeability in the Adalimumab Market

September 10th 2023

By Skylar Jeremias

Video

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, explains the value of interchangeability in the adalimumab space and predicts whether interchangeable biosimilars will become leaders in adoption.

Regulatory Updates From Around the Globe Provide Hope for Biosimilars

September 9th 2023

By Skylar Jeremias

Article

An approval in Australia and positive recommendations for 2 biosimilars in Europe bring hope for more affordable biologics around the world. However, another settlement for a US ustekinumab biosimilar showcases that some barriers remain.