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FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job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

Medicare Modeling Shows Major Savings With Biosimilar Bevacizumab Use

December 9th 2025

By Skylar Jeremias

Article

Biosimilar bevacizumab offers significant cost savings for Medicare, enhancing treatment access for metastatic colorectal and lung cancer patients without increasing spending.

Biosimilar QL1207 Demonstrates Equivalent Efficacy and Safety in DME

December 8th 2025

By Skylar Jeremias

Article

Swiss Analysis Shows Biosimilars Cut Costs but Longer-Interval Options Lead Savings

December 4th 2025

By Skylar Jeremias

Article

Explore the cost-effectiveness of ranibizumab biosimilars versus aflibercept in treating AMD and DME, revealing significant savings and treatment implications.

Biosimilars News Roundup: Approvals Surge Amid Policy Changes

December 2nd 2025

By Skylar Jeremias

Article

November 2025 highlights FDA approvals for denosumab and pertuzumab biosimilars, enhancing competition and access in oncology and bone health markets.

All Things Biosimilars: How Streamlined CES Rules Could Shift the Market

November 30th 2025

By Skylar Jeremias

Podcast

In this special video episode of Not So Different, co-hosts Giuseppe Randazzo and Alex Keeton from the Association of Accessible Medicines tackle the FDA's recent draft guidance on comparative efficacy studies (CES) and interchangeability for biosimilars, addressing some of the confusion around the new announcement and remaining action items for the agency.

Biosimilar Interchangeability and Substitution in the US: What Comes Next?

November 27th 2025

By Benjamin N. Rome, MD, MPH

Article

Changing the FDA biosimilar interchangeability standards is a necessary but likely insufficient step to improve biosimilar competition in the US.

Economic Analysis Supports Formulary Shift to Biosimilar Denosumab

November 26th 2025

By Skylar Jeremias

Article

Biosimilar denosumab offers significant cost savings and improved access to treatment, alleviating financial burdens in oncology care while enhancing patient outcomes.

Patient Experiences With CT-P17 Suggest Strong Satisfaction and Ease of Injection

November 25th 2025

By Skylar Jeremias

Article

Patients with Crohn disease report high satisfaction and minimal discomfort using the citrate-free biosimilar CT-P17, enhancing adherence to treatment.

Real-World Data Highlight Adalimumab Biosimilar Options for Hidradenitis Suppurativa

November 21st 2025

By Skylar Jeremias

Article

New research reveals that switching from originator to biosimilar adalimumab for hidradenitis suppurativa may lead to reduced treatment effectiveness and stability.

FDA Approves Poherdy: First Interchangeable Biosimilar to Perjeta

November 18th 2025

By Skylar Jeremias

Article

FDA approves Poherdy, the first interchangeable biosimilar for pertuzumab (Perjeta), enhancing competition in HER2-positive breast cancer treatment.