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 ...

Biologic drugs, made from living organisms and usually taken by injection or infusion, are expensive treatments for complex chronic conditions such as cancer and autoimmune diseases. Biosimilars, ...

FDA-approved carbon copies of brand-name drugs with expired patents—over the last 30 years, these generic drugs have saved ...

Opinions expressed by Digital Journal contributors are their own. Bringing a new biologic drug from concept to clinic is a complex journey fraught with technical and regulatory hurdles. For ...

Health and Human Services Secretary Robert F. Kennedy Jr. unveiled a new plan on Wednesday that he said will drastically reduce drug prices in the U.S. He said the U.S. Food and Drug Administration is ...

(CNN) — The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

A new procedural document issued by the US Food and Drug Administration (FDA) instructs its staff on the best practices-known as Good Review Practices (GVPs)-used in the review of investigational new ...

Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. From ...

The Biologics Price Competition and Innovation Act of (BPCI Act) of 2009 granted responsibility to the FDA for review and approval of a new class of pharmaceuticals referred to as “Biosimilars.” (1) ...

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 ...