Truxima Rituximab
El primer biosimilar de rituximab con evidencia demostrada 1
El medicamento está sujeto a seguimiento adicional, es prioritaria la notificación
de sospechas de reacciones adversas asociadas a este medicamento.
Truxima, tratamiento de elección con todas las garantías
Iniciamos un camino en el que nos consolidamos como una alternativa innovadora, segura, eficaz y al alcance de todos.
Truxima® es Rituximab 1
Truxima® ha sido aprobado por la EMA para las mismas indicaciones que el fármaco de referencia. 1,2
Evidencia demostrada
Trazabilidad garantizada
Un nuevo paradigma, una nueva oportunidad
Referencias:
1. European Medicines Agency. Truxima -EMEA/H/C/004112 -N/0001. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_ Product_Information/human/004112/WC500222694.pdf. 2. Ficha técnica de Truxima®. 3. European Medicines Agency. Questions and answers on biosimilar medicines (similar biological medicinal products) EMA/837805/2011. 4. Dalakas MC (2008) B cells as therapeutic targets in autoimmune neurological disorders Nat Clin Pract Neurol 10.1038/ncpneuro0901. 5. Yoo DH et al. A multicentre randomised controlled trial to compare the pharmacokinetics, eficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis. Ann Rheum Dis. 2017;76(3):566-70. 6. Data on file. Celltrion Healthcare. January 2017. 7. Yoo DH et al. Efficacy and Safety of Switching from Innovator Rituximab to Biosimilar CT-P10 Compared with Continued Treatment with CT-P10: Results of a 56-Week Open-Label Study in Patients with Rheumatoid Arthritis. BioDrugs. 2017 Aug;31(4):369-377. 8. Suh CH et al. Pharmacokinetics and Safety of Three Formulations of Rituximab (CT-P10, US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10).http://acrabstracts.org/abstract/pharmacokinetics-and-safety-of-three-formulations-of-rituximab-ct-p10-us-sourced-innovator-rituximab-and-eu-sourced-innovator-rituximabin-patients-with-rheumatoid-arthritis-results-from-phase-3-r/. Accessed May 15, 2017. 9. Yoo DH, Bozic Majstorovic L, Berrocal Kasay A, et al. Ef_ cacy and Safety of CT-P10, Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). http://acrabstracts.org/abstract/ef_ cacy-and-safety-of-ct-p10-rituximab-biosimilarcandidate- and-innovator-rituximab-in-patients-with-rheumatoid-arthritis-results-from-phase-3-randomized-controlled-trial-over-24-weeks/. Accessed May 16, 2017. 10. Coifer B, Sancho JM, Jurczak W, et al. Pharmacokinetic and Safety of CT-P10, a Biosimilar Candidate to the Rituximab Reference Product, in Patients with Newly Diagnosed Advanced Stage Follicular Lymphoma (AFL) [Abstract] presented at ASH 2016; 3-6 Dec 2016.
