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

The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...

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) , a sweeping guidance that codifies multiple regulatory ...

Aydin Harston Ph.D., Alexander Shaver Ph.D. FDA approves Omylco® (omalizumab), first biosimilar of Xolair®. After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025.

Biosimilars are gaining traction as competitors aim to capture market share from branded biologics such as Humira and Neulasta. Humira now faces competition from seven biosimilars, while Neulasta has ...

The US biosimilar market has grown significantly, with a 97% compound annual growth rate since 2015, but adoption varies across therapeutic areas. Health plan policies play a crucial role in ...

Changing the FDA biosimilar interchangeability standards is a necessary but likely insufficient step to improve biosimilar competition in the US. In 2009, Congress created a regulatory pathway for ...

Forbes contributors publish independent expert analyses and insights. Ge Bai is professor of accounting & health policy at Johns Hopkins. Biologic drugs, made from living organisms and usually taken ...

The Food and Drug Administration is relaxing regulations on biosimilar drugs used for cancer and rare diseases in the hopes of boosting competition and lowering prices for high-cost pharmaceuticals.

The FDA released draft guidance indicating it may approve certain biosimilars without requiring a comparative efficacy study (CES), traditionally a costly and time-intensive step. Instead, advances in ...