Biosimilar Tracker

Track every biosimilar in the global pipeline by originator drug. Approved biosimilars, filed under review, Phase 3 candidates, and the originator's patent timeline. Free + updated daily from FDA Purple Book + EMA EPAR.

Every biosimilar in our index, organised by originator. Each page shows approved biosimilars, filed applications under regulatory review, Phase 3 candidates, and the originator's patent timeline — so you can see exactly when each cliff opens.

Tracked originators

How biosimilar approval works

Biosimilars are biological medicines highly similar to an already-approved originator (reference biologic). Approval happens via an abbreviated pathway — FDA 351(k) BLA, EMA biosimilar guideline — that relies on comparison studies rather than full clinical re-development. The door opens once the originator's data exclusivity and patents lapse in the relevant territory.

Why biosimilars matter

• Payers: typical 15–35% list-price discount vs originator; volume-weighted savings far higher
• Originators: ~30–50% revenue erosion within 24 months of biosimilar entry (varies by class)
• Patients: expanded access in price-sensitive markets
• Pipeline strategy: originators defend with formulation patents, next-gen molecules, indication expansion

Related

• 2026 patent cliff calendar
• Upcoming PDUFA dates
• Build a custom biosimilar feed