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Tag: FDA guidance 2025

Biosimilar Approval: How the FDA Reviews Biologic Alternatives in 2026
By Vincent Kingsworth 13 Jan 2026

Biosimilar Approval: How the FDA Reviews Biologic Alternatives in 2026

The FDA updated its biosimilar approval process in late 2025 to speed up access to cheaper biologic alternatives. Learn how analytical data now replaces costly clinical trials, what interchangeability really means, and why savings could reach $150 billion annually.

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