FDA to streamline approvals of generic biologic drugs

FDA Launches Effort to Ease Approval Pathway for Biosimilars

(MedPage Today) -- 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 released guidance to simplify...

RFK Jr. Seeks To Accelerate Approvals for Lower-Cost Generic Alternatives to Expensive Biologic Drugs

The proposal could cut in half the time and cost of approval of new generics.

FDA to streamline approvals of generic biologic drugs

FDA proposes streamlined approval process for biosimilars to lower health costs, potentially cutting development time and expenses for companies.

RFK Jr. to speed up development and availability of low-cost alternatives to the costliest drugs

The Trump administration moved Wednesday to accelerate the development and availability of a broad class of low-cost, competitive drugs that promise to cut billions of dollars in U.S. spending on pharmaceuticals for diabetes, cancer and other conditions.

FDA Says It’s Eliminating Requirements for Generic Versions of Expensive Drugs

Health officials announced on Oct. 29 that they are proposing the elimination of testing requirements for biosimilars, or generic versions of biologic drugs. The Food and Drug Administration in draft guidance said it will reduce instances where large human trials are required for biosimilars. If a comparative analytical assessment shows that a biosimilar is similar to a biologic, then a comparative efficacy study “may not be necessary,” the guid…

FDA moves to ease path for biosimilars as Trump seeks to cut drug costs

The FDA wants to make it quicker to approve biosimilars, part of President Trump's efforts to lower U.S. drug prices.