All News

BioRationality: FDA Issues New Guidance on Promotional Communications for Biosimilar Products

December 11th 2025

By Sarfaraz K. Niazi, PhD

FDA's new guidance clarifies promotional practices for biosimilars, ensuring accurate marketing and preventing misleading claims in the competitive landscape.

Medicare Modeling Shows Major Savings With Biosimilar Bevacizumab Use

December 9th 2025

By Skylar Jeremias

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

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

December 4th 2025

By Skylar Jeremias

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

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

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co-hosts Giuseppe Randazzo and Alex Keeton from the Association of Accessible Medicines tackle the FDA's recent draft guidance on comparative efficacy studies (CES) and interchangeability for biosimilars, addressing some of the confusion around the new announcement and remaining action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

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

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

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

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