Last reviewed · How we verify

Stelara biosimilars

Complete Stelara (ustekinumab) biosimilar landscape: 9 approved biosimilars, 0 filed, 5 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

9 approved 0 filed 5 Phase 3 All key patents expired

About Stelara

Stelara (ustekinumab) — originally marketed by Johnson & Johnson. Target: p40 protein subunit of IL-12 and IL-23. Area: Immunology.

Approved biosimilars (9)

BiosimilarSponsorPhaseFirst approvalCountry
PYZCHIVA SAMSUNG BIOEPIS CO LTD marketed
IMULDOSA ACCORD BIOPHARMA INC. marketed
OTULFI FRESENIUS KABI USA marketed
STEQEYMA CELLTRION, INC. marketed
SELARSDI ALVOTECH USA INC marketed
WEZLANA AMGEN INC marketed
Ustekinumab and Upadacitinib Sixth Affiliated Hospital, Sun Yat-sen University marketed
Ustekinumab Injection National Medical Research Center for Children's Health, Russian Federation marketed
Ustekinumab (UST) Second Affiliated Hospital, School of Medicine, Zhejiang University marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (5)

BiosimilarSponsorPhaseFirst approvalCountry
Ustekinumab - Standard Dosage Humanitas Clinical and Research Center phase 3
Ustekinumab (90 mg) Janssen Scientific Affairs, LLC phase 3
Ustekinumab IV Janssen Research & Development, LLC phase 3
Ustekinumab - Half-Standard Dosage Janssen Research & Development, LLC phase 3
Ustekinumab SC Janssen Research & Development, LLC phase 3

Originator patent timeline

Active patents (0)

No active patents tracked.

Expired patents (0)

No expired patents tracked.

Subscribe to biosimilar updates

Every regulatory action on Stelara or any of its biosimilars:

Related