FDA Cuts Testing Requirements for Biosimilars Once Again

FDA cuts testing requirements for biosimilars once again

The FDA has issued additional guidance that aims to make it easier for drugmakers to bring biosimilars of patent-expired biologic drugs to market.

FDA Issues Landmark Biosimilar Guidance Incorporating Regulatory Reforms Advised by Professor Niazi: Further Cutting Development Costs by Up to 50%

/PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today released New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)1,...

FDA Plans to Loosen Testing Rules to Boost Biosimilar Drugs

The US Food and Drug Administration is easing some requirements for drugmakers developing copycat versions of costly biologic medications in a bid to bring more competition to the market and lower costs.

PCMA Supports Trump Administration’s Action to Increase Biosimilars Access

Now, Congress Should Make Biosimilars Interchangeable (Washington, D.C.) – The Trump Administration is taking action to increase access to biosimilars. Congress can take the administration’s lead and entirely eliminate the interchangeability designation for biosimilars. In response to the new draft guidance, issued yesterday by the Food and Drug Administration, Pharmaceutical Care Management Association President and CEO, David Marin, issued the…

AAM and Biosimilars Council praise FDA plan to simplify biosimilar development

WASHINGTON — The Association for Accessible Medicines and its Biosimilars Council praised FDA's updated guidance to reduce costs and streamline biosimilar development. The FDA now allows originators to cite existing comparative data, not just from the U.S., for clinical pharmacokinetic testing comparing biosimilars to reference biologics. It also removes the need for duplicative comparative studies.“AAM and the Biosimilars Council thank Dr. Maka…

FDA homes in on biosimilar accessibility in new draft guidance - Pharmaceutical Technology

This new framework is the FDA's second scheme designed to streamline biosimilar development in the hopes of lowering drug prices.