JD Supra

FDA's Biosimilar Playbook: Merging Biosimilarity with Interchangeability

The Development: The Food and Drug Administration ("FDA") issued two draft guidance documents that would largely eliminate clinical efficacy and switching studies and instead rely on the precision of ...
Hosted on MSN

FDA Launches Effort to Ease Approval Pathway for Biosimilars

Federal regulators are trying to make it easier to develop cheaper alternatives to biologics that many Americans depend on to treat autoimmune diseases or cancers. The FDA said Wednesday it has ...
JD Supra

FDA Policy Changes Could Bring Some Biosimilars to Market Faster

The Food and Drug Administration (FDA) recently announced changes to its policy on when a comparative efficacy study would be required to demonstrate biosimilarity. In essence, FDA is lopping off the ...
Medscape

FDA Aims to Streamline Biosimilar Drug Development

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...
abc27

Professor Sarfaraz K. Niazi Files Landmark Citizen Petition Urging the FDA to Modernize Biosimilar Approval Pathways and Transform Global Access to Biological Medicines

CHICAGO, Dec. 8, 2025 /PRNewswire/ -- Professor Sarfaraz K. Niazi, Ph.D., a leading authority in pharmaceutical sciences and internationally recognized biosimilars expert, has filed a major Citizen ...
Becker's Hospital Review

FDA rewrites biosimilar rules to slash drug costs

HHS Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary, MD, and CMS Administrator Mehmet Oz, MD, announced new FDA guidance aimed at making biosimilar drug development faster and less ...