Oct 29, 2025 · With today’s action, the FDA aims to help more companies bring affordable, high-quality biosimilars to market and reduce costs for the American people.

This blog explores key biosimilar approvals by FDA in 2025, and how global pharmaceutical innovation is reshaping healthcare economics.

Jul 16, 2025 · Between newly approved agents, relaxed FDA requirements, and a maturing biosimilar developer ecosystem, the U.S. pipeline for 2025-2029 is poised to deliver wider …

May 31, 2025 · Presented by The Center for Biosimilars ® in partnership with AAM and the Biosimilars Council, this series explores the critical challenge of the "biosimilar void" — where …

6 days ago · While the FDA is streamlining regulation of copycat versions of the expensive drugs that millions take for arthritis, cancer, and other diseases, the U.S. patent office is making it …

Nov 2, 2025 · PEGINTRON’s future hinges on its potential repositioning within niche markets and ongoing clinical evaluations. While its role in mainstream hepatitis C management has …

3 days ago · The FDA has issued draft guidance recommending that all biosimilar medications be designated as interchangeable with their reference products upon initial FDA approval. A 60 …

Nov 10, 2025 · With new draft guidance, FDA continues prior efforts to reduce the need for comparative clinical studies in biosimilar development and speed new products to market.

Nov 13, 2025 · There have been 77 biosimilars approved by the U.S. Food and Drug Administration (FDA). The most recent biosimilar approval was Poherdy (pertuzumab-dpzb) on …

As of January 2025, for example, Humira ®, typically the top biologic medication in terms of pharmacy expenditures, has 10 FDA-approved biosimilars (several are considered …