Policy

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.

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co-hosts Giuseppe Randazzo and Alex Keeton from the Association of Accessible Medicines tackle the FDA's recent draft guidance on comparative efficacy studies (CES) and interchangeability for biosimilars, addressing some of the confusion around the new announcement and remaining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

Webinar: Aligning Biosimilar Access Policy With Global Health Priorities

November 14th 2025

By Skylar Jeremias

FDA Quietly Approves Denosumab Biosimilars, Issues Interchangeability for Others

November 13th 2025

By Skylar Jeremias

FDA approves multiple denosumab biosimilars, enhancing market access and introducing interchangeability, boosting competition in bone health therapies.

Global Data Show Variety in Adalimumab Biosimilar Design, Patient Support Systems

November 7th 2025

By Skylar Jeremias

New findings explore the adalimumab biosimilar landscape, focusing on formulation, devices, and patient support programs that enhance treatment experiences.

UK Experts Publish Guidance on JC Virus Testing for Natalizumab Biosimilar Tyruko

November 5th 2025

By Skylar Jeremias

UK neurologists release new guidelines for JC virus testing in patients using the natalizumab biosimilar Tyruko, addressing safety and monitoring challenges.

A Closer Look at New FDA Guidance Removing Barriers to Biosimilar Development

October 30th 2025

By Skylar Jeremias

FDA's new guidance streamlines biosimilar development, reducing costs and regulatory hurdles and potentially enhancing market access and affordability.

BioRationality: The FDA Sets Sights on Removing Clinical Efficacy Studies for Biosimilars

October 29th 2025

By Sarfaraz K. Niazi, PhD

FDA Approves Celltrion Aflibercept Biosimilar: Eydenzelt

October 13th 2025

By Skylar Jeremias

The FDA has approved Celltrion's Eydenzelt, a new aflibercept biosimilar, enhancing treatment options for retinal diseases in the US.