Tag: FDA biosimilars

Biosimilar Approval: How the FDA Reviews Biologic Alternatives in 2026

Biosimilar Approval: How the FDA Reviews Biologic Alternatives in 2026
wayne Holloway in: Medications 16 January 2026

The FDA's 2025 guidance streamlines biosimilar approval by replacing costly clinical trials with advanced analytical data, accelerating access to lower-cost biologic alternatives for cancer, arthritis, and diabetes. Learn how the process works and what's still holding it back.

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Biosimilar Approval: How the FDA Reviews Biologic Alternatives in 2026
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