How many Keytruda biosimilars are approved?

Drug Landscape tracks 1 approved Keytruda biosimilars across global regulators. 0 additional applications are filed and 17 are in Phase 3.

Is Keytruda still patent-protected?

All tracked patents on Keytruda 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 2026-06-10 · How we verify

Keytruda biosimilars

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

Complete Keytruda (pembrolizumab) biosimilar landscape: 1 approved biosimilars, 0 filed, 17 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

1 approved 0 filed 17 Phase 3 All key patents expired

About Keytruda

Keytruda (pembrolizumab) — originally marketed by Merck & Co.. Class: Monoclonal antibody; PD-1 inhibitor. Target: PD-1 receptor. Area: Oncology. First approved 2014-09-04.

Approved biosimilars (1)

Biosimilar	Sponsor	Phase	First approval	Country
Pembrolizumab Injection	OncXerna Theraputics, Inc.	marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (17)

Biosimilar	Sponsor	Phase
Pembrolizumab Formulated with Berahyaluronidase Alfa	Merck Sharp & Dohme LLC	phase 3
Pembrolizumab (K)	Merck Sharp & Dohme LLC	phase 3
Pembrolizumab placebo (saline)	Merck Sharp & Dohme LLC	phase 3
Pembrolizumab, Sintilimab	Hunan Province Tumor Hospital	phase 3
Pembrolizumab/Vibostolimab	Merck Sharp & Dohme LLC	phase 3
Pembrolizumab biosimilar	Laboratorio Elea Phoenix S.A.	phase 3
Pembrolizumab IV	Merck Sharp & Dohme LLC	phase 3
Pembrolizumab/Quavonlimab	Merck Sharp & Dohme LLC	phase 3
Pembrolizumab SC	Merck Sharp & Dohme LLC	phase 3
Pembrolizumab (MK-3475)	Memorial Sloan Kettering Cancer Center	phase 3
pembrolizumab (200 mg)	Eisai Co., Ltd.	phase 3
Pembrolizumab (EU)	Amgen	phase 3
Pembrolizumab Monotherapy	PDS Biotechnology Corp.	phase 3
Pembrolizumab and Chemotherapy drugs	University Hospital, Brest	phase 3
Pembrolizumab (US)	Amgen	phase 3
Pembrolizumab with Optional Crossover Period	Iovance Biotherapeutics, Inc.	phase 3
Pembrolizumab/Vibostolimab Co-Formulation	Merck Sharp & Dohme LLC	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 Keytruda or any of its biosimilars:

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