How many Xolair biosimilars are approved?

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

Is Xolair still patent-protected?

All tracked patents on Xolair 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 2026-05-15 · How we verify

Xolair biosimilars

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

2 approved 0 filed 2 Phase 3 All key patents expired

About Xolair

Xolair (omalizumab) — originally marketed by Roche. Class: Anti-IgE [EPC]. Target: Ig epsilon chain C region. Area: Immunology.

Approved biosimilars (2)

Biosimilar	Sponsor	Phase	First approval	Country
Omalizumab (Xolair)	McMaster University	marketed
Omalizumab Injection	Rigshospitalet, Denmark	marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (2)

Biosimilar	Sponsor	Phase	First approval	Country
Omalizumab for injection	CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.	phase 3
Omalizumab (CinnaGen)	Cinnagen	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 Xolair or any of its biosimilars: