How many Ibrance biosimilars are approved?

Drug Landscape tracks 2 approved Ibrance biosimilars across global regulators. 0 additional applications are filed and 3 are in Phase 3.

Is Ibrance still patent-protected?

All tracked patents on Ibrance have expired in tracked territories.

What is a biosimilar?

A biosimilar is a biological medicine highly similar to an already-approved reference biologic (the originator), with no clinically meaningful differences in safety, purity, or potency. Approved via abbreviated regulatory pathways once the originator's data exclusivity and patents expire.

Last reviewed 2026-06-09 · How we verify

Ibrance biosimilars

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Complete Ibrance (Palbociclib) biosimilar landscape: 2 approved biosimilars, 0 filed, 3 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

2 approved 0 filed 3 Phase 3 All key patents expired

About Ibrance

Ibrance (Palbociclib) — originally marketed by Pfizer. Class: CDK4/6 inhibitor. Target: Cyclin-dependent kinases 4 and 6 (CDK4/6). Area: Oncology. First approved 2015-01-01.

Approved biosimilars (2)

Biosimilar	Sponsor	Phase	First approval	Country
Palbociclib	Pfizer Inc.	marketed
Palbociclib in combination with AI	Pfizer	marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (3)

Biosimilar	Sponsor	Phase
Palbociclib PD-0332991	GBG Forschungs GmbH	phase 3
Palbociclib + Letrozole	Pfizer	phase 3
Palbociclib + Letrozole OR Fulvestrant	SOLTI Breast Cancer Research Group	phase 3

Originator patent timeline

Active patents (0)

No active patents tracked.

Expired patents (0)

No expired patents tracked.

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Every regulatory action on Ibrance or any of its biosimilars:

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing