References
- Swerdlow SH, Campo E, Pileri SA, et al. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016;127(20):2375–2390.
- Rovira J, Valera A, Colomo L, et al. Prognosis of patients with diffuse large B cell lymphoma not reaching complete response or relapsing after frontline chemotherapy or immunochemotherapy. Ann Hematol. 2015;94(5):803–812.
- Dotan E, Aggarwal C, Smith MR. Impact of rituximab (Rituxan) on the treatment of B-cell non-Hodgkin’s lymphoma. P T. 2010;35(3):148–157.
- Pfreundschuh M, Trumper L, Osterborg A, et al. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006;7(5):379–391.
- Feugier P, Van Hoof A, Sebban C, et al. Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: a study by the Groupe d’Etude des Lymphomes de l’Adulte. JCO. 2005;23(18):4117–4126.
- Khor S, Beca J, Krahn M, et al. Real world costs and cost-effectiveness of rituximab for diffuse large B-cell lymphoma patients: a population-based analysis. BMC Cancer. 2014;14(1):586.
- Baer Ii WH, Maini A, Jacobs I. Barriers to the access and use of rituximab in patients with non-Hodgkin’s lymphoma and chronic lymphocytic leukemia: a physician survey. Pharmaceuticals (Basel). 2014;7(5):530–544.
- Yoo DH, Suh CH, Shim SC, et al. A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis. Ann Rheum Dis. 2017;76(3):566–570.
- Park W, Bozic-Majstorovic L, Milakovic D, et al. Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial. MAbs. 2018;10(6):934–943.
- Kim WS, Ogura M, Buske C, et al. Global Phase I/III pharmacokinetic and efficacy study comparing CT-P10, a biosimilar candidate to the rituximab reference product in patients with advanced stage follicular lymphoma (AFL). Blood. 2015;126(23):5111–5111.
- Kim WS, Buske C, Ogura M, et al. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 compared with rituximab in patients with previously untreated advanced-stage follicular lymphoma: a randomised, double-blind, parallel-group, non-inferiority phase 3 trial. Lancet Haematol. 2017;4(8):e362–e373.
- US Food and Drug Administration. FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma. 2018 [cited 8 Dec 2019]. https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treatment-adult-patients-non-hodgkins-lymphoma.
- Kim WS, Coiffier B, Kwon HC, et al. Clinical development of CT-P10 and other biosimilar cancer therapeutics. Future Oncol. 2017;13(15s):31–44.
- Hans CP, Weisenburger DD, Greiner TC, et al. Confirmation of the molecular classification of diffuse large B-cell lymphoma by immunohistochemistry using a tissue microarray. Blood. 2004;103(1):275–282.
- Younes A, Hilden P, Coiffier B, et al. International Working Group consensus response evaluation criteria in lymphoma (RECIL 2017). Ann Oncol. 2017;28(7):1436–1447.
- Coleman M, Lammers PE, Ciceri F, et al. Role of rituximab and rituximab biosimilars in diffuse large B-cell lymphoma. Clin Lymphoma Myeloma Leuk. 2016;16(4):175–181.
- Greenwald M, Tesser J, Sewell KL. Biosimilars have arrived: rituximab. Arthritis. 2018;2018:1–6.
- Lo I, Bansal S, Arami S. The safety and efficacy of the biosimilar anti-CD20 antibody, Truxima, in heamatological malignancy: PB2263. HemaSphere. 2019;3:1012–1013.
- US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. 2015 [cited 8 Dec 2019]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/scientific-considerations-demonstrating-biosimilarity-reference-product.
- Rugo HS, Linton KM, Cervi P, et al. A clinician’s guide to biosimilars in oncology. Cancer Treat Rev. 2016;46:73–79.
- Ogura M, Coiffier B, Kwon H-C, et al. Scientific rationale for extrapolation of biosimilar data across cancer indications: case study of CT-P10. Future Oncol. 2017;13(15s):45–53.
- Cheesman S, Shah R, Lambert J, et al. Responses to R-CHOP chemotherapy incorporating biosimilar rituximab (Truxima®) for the first line treatment of diffuse large B-cell lymphoma - initial experience at University College London Hospital: PF312. HemaSphere. 2019;3:108–109.
- Bishton M, Turner D, Marshall S, et al. Real world clinical effectiveness and safety of CT-P10 in patients with diffuse large B-cell lymphoma: interim results from a European non-interventional post-authorisation safety study: PF314. HemaSphere. 2019;3:109–110.
- Horvat M, Zadnik V, Juznic ST, et al. Diffuse large B-cell lymphoma: 10 years’ real-world clinical experience with rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisolone. Oncol Lett. 2018;15:3602–3609.
- European Medicines Agency. Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues. 2012 [cited 8 Dec 2019]. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-monoclonal-antibodies-non-clinical_en.pdf
- Kaplanov K, Zaritskiy A, Alexeev S, et al. Key results of international randomized open-label clinical study of BCD-020 (rituximab biosimilar candidate) in patients with B-cell non-Hodgkin’s lymphoma. Blood. 2014;124(21):5467–5467.
- Florez A, Di Matteo T, Fresnillo G, et al. Clinical pharmacokinetic (PK) and safety (immunogenicity) of rituximab biosimilar RTXM83 in combination with chemotherapy CHOP in patients with diffuse large B-cell lymphoma (DLBCL). Blood. 2014;124(21):5472–5472.
- Ogura M, Sancho JM, Cho S-G, et al. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial. Lancet Haematol. 2018;5(11):e543–e553.
- Hu X, Zeng M, Yang SE, et al. Efficacy of rituximab combined with CHOP for treating patients with diffuse large B-cell lymphoma. Medicine (Baltimore). 2017;96(45):e8494.
- Cunningham D, Hawkes EA, Jack A, et al. Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone in patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: a phase 3 comparison of dose intensification with 14-day versus 21-day cycles. Lancet. 2013;381(9880):1817–1826.
- Leonard JP, Kolibaba KS, Reeves JA, et al. Randomized Phase II study of R-CHOP with or without bortezomib in previously untreated patients with non-germinal center B-cell-like diffuse large B-cell lymphoma. JCO. 2017;35(31):3538–3546.
- Seymour JF, Pfreundschuh M, Trneny M, et al. R-CHOP with or without bevacizumab in patients with previously untreated diffuse large B-cell lymphoma: final MAIN study outcomes. Haematologica. 2014;99(8):1343–1349.
- Vitolo U, Trněný M, Belada D, et al. Obinutuzumab or rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated diffuse large B-cell lymphoma. JCO. 2017;35(31):3529–3537.
- Suh CH, Yoo DH, Berrocal Kasay A, et al. Long-term efficacy and safety of biosimilar CT-P10 versus innovator rituximab in rheumatoid arthritis: 48-week results from a randomized Phase III trial. BioDrugs. 2019;33(1):79–91.