The administration announced some proposals for the Food And Drug Administration. (Sarah Silbiger/Getty Images) The Trump administration is proposing changes to Food and Drug Administration guidelines ...

This framework is the second that the agency has introduced in recent months to streamline biosimilar development in the hopes of lowering drug prices.

FDA looks further ease biosimilar approvals by allowing foreign clinical data and reducing pharmacokinetic study requirements to cut costs.

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...

Biologics are complex medications produced through biological processes or from living organisms such as proteins and genes. Biosimilars are what they sound like — similar to, but not the same as, an ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

The Food and Drug Administration said it will take steps to speed up the process of developing generic versions of complex biological drugs, in a bid to increase cheaper competition for expensive ...

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 ...

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...

Please provide your email address to receive an email when new articles are posted on . An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy ...

WASHINGTON - The Food and Drug Administration announced Wednesday that it plans to streamline the approval process for cheaper, "biosimilar" alternatives to biologic drugs in an effort to reduce ...