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Mabthera biosimilars

Complete Mabthera (rituximab) biosimilar landscape: 15 approved biosimilars, 0 filed, 19 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

15 approved 0 filed 19 Phase 3 All key patents expired

About Mabthera

Mabthera (rituximab) — originally marketed by Roche. Class: CD20-directed Cytolytic Antibody [EPC]. Target: B-lymphocyte antigen CD20. Area: Oncology. First approved 1997-01-01.

Approved biosimilars (15)

BiosimilarSponsorPhaseFirst approvalCountry
Mabthera Roche marketed 1997-01-01
RITUXIMAB marketed 1997-01-01
rituximab and everolimus National Taiwan University Hospital marketed
RIABNI AMGEN INC marketed
rituximab [MabThera/Rituxan] Hoffmann-La Roche marketed
RiTUXimab Injection [Truxima] Laida Cuevas Palomares marketed
Rituximab Fludarabine Cyclophosphamide Asociacion Espanola de Hematologia y Hemoterapia marketed
Rituximab-pvvr National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) marketed
TRUXIMA CELLTRION INC marketed
Rituximab Injection Hopital Foch marketed
rituximab combined with corticosteroids First Affiliated Hospital, Sun Yat-Sen University marketed
Rituximab 375 University Hospital, Toulouse marketed
rituximab 1000 University Hospital, Toulouse marketed
Rituximab infusion Centre Hospitalier Universitaire de Saint Etienne marketed
Rituximab (R) National Cancer Institute (NCI) marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (19)

BiosimilarSponsorPhaseFirst approvalCountry
Rituximab, Methotrexate, Temozolomide Assistance Publique - Hôpitaux de Paris phase 3
Rituximab - CVP The Lymphoma Academic Research Organisation phase 3
Rituximab (Mabthera) Shereen Medhat Mohammed Elsayed Nassar phase 3
RITUXIMAB + DHAP GlaxoSmithKline phase 3
Rituximab Monotherapy Beijing Friendship Hospital phase 3
Rituximab (US) Amgen phase 3
Rituximab and Hyaluronidase Human National Cancer Institute (NCI) phase 3
Rituximab IV Hoffmann-La Roche phase 3
Rituximab plus CHOP Sinocelltech Ltd. phase 3
Rituximab (Arm B) Ostfold Hospital Trust phase 3
rituximab maintenance Ludwig-Maximilians - University of Munich phase 3
Rituximab window University Hospital Muenster phase 3
Rituximab (EU) Amgen phase 3
Rituximab (Arm A) Assistance Publique - Hôpitaux de Paris phase 3
rituximab+chlorambucil International Extranodal Lymphoma Study Group (IELSG) phase 3
Rituximab Biosimilar Merck Sharp & Dohme LLC phase 3
Rituximab sc Diako Ev. Diakonie-Krankenhaus gemeinnützige GmbH phase 3
Rituximab-HDS Gruppo Italiano Terapie Innovative nei Linfomi phase 3
Rituximab - CHOP The Lymphoma Academic Research Organisation 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 Mabthera or any of its biosimilars:

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