Tag: FDA guidance 2025

Biosimilar Approval: How FDA Reviews Biologic Alternatives in 2026

• Cheryl Moran
• February 14, 2026
• 1 Comments

The FDA overhauled its biosimilar approval process in 2025, removing costly clinical trials and speeding up access to lower-cost biologic alternatives. Here’s how it works now - and why it matters for patients and providers.