FDA Aims to Accelerate Biosimilar Development as Way to Reduce Drug Costs

Health Secretary RFK Jr. announces new FDA move to fast-track biosimilar drug approvals

Federal regulators are trying to make it easier to develop cheaper alternatives to powerful drugs that many Americans depend on to treat autoimmune diseases or cancers.

FDA Says It’s Eliminating Requirements for Generic Versions of Expensive Drugs - The Thinking Conservative News

The Food and Drug Administration in draft guidance said it will reduce instances where large human trials are required for biosimilars. The post FDA Says It’s Eliminating Requirements for Generic Versions of Expensive Drugs appeared first on The Thinking Conservative News.

FDA aims to accelerate biosimilar development as way to reduce drug costs

The FDA today unveiled a plan to accelerate development of biosimilars in hopes of significantly reducing drug costs in the United States.The agency issued draft guidance that would simplify the study of biosimilars and reduce what officials characterized as time-consuming, costly and unnecessary clinical testing.

FDA Eases Biosimilar Approval Requirements to Lower Drug Costs

The Food and Drug Administration has unveiled new guidance to accelerate the approval of biosimilars, the lower-cost versions of complex biologic drugs. Under the new policy, developers will no longer be required to conduct human trials comparing biosimilars to branded biologics if their products meet certain analytical and manufacturing criteria. The FDA estimates this change could save companies $100 million per product in development costs, e…

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

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

FDA Guidance to Remove One of the Largest Barriers to Biosimilar Development

The FDA announced draft guidance to remove clinical efficacy studies for biosimilars and also issued the position that all biosimilars in the US should be interchangeable.