2019
DOI: 10.1007/s40259-019-00398-7
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A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera®) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL)

Abstract: Background Biosimilars are highly similar to the licensed biologic ("reference product"), with no clinically meaningful differences in safety, purity, or potency between the two products. Objective This comparative 52-week clinical study evaluated the efficacy, safety, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-05280586 (Ruxience™ [a rituximab biosimilar]) versus rituximab reference product sourced from the EU (MabThera ® ; rituximab-EU). Patients and Methods Subjects with CD20-posi… Show more

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Cited by 37 publications
(48 citation statements)
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“…Eight biosimilars of rituximab have been approved by a regulatory health authority with preclinical and clinical information. 69 – 82 From all these biosimilars, only four were approved after conducting a comparative trial in DLBCL patients.…”
Section: Rituximab Biosimilarsmentioning
confidence: 99%
“…Eight biosimilars of rituximab have been approved by a regulatory health authority with preclinical and clinical information. 69 – 82 From all these biosimilars, only four were approved after conducting a comparative trial in DLBCL patients.…”
Section: Rituximab Biosimilarsmentioning
confidence: 99%
“…35 The phase 3 study (NCT02213263) of PF-05280586 displayed positive results as well. 36 Moreover, ABP798 is currently under study (NCT02747043).…”
Section: Cd20mentioning
confidence: 99%
“…Most manufacturers have designed clinical efficacy and safety comparisons between the candidate and the RMP in the setting of NHL. Sandoz (GP2013) chose to conduct its efficacy trial in combination with cyclophosphamide, vincristine, and prednisone in patients with advanced FL [53], whereas Pfizer (PF-05280586) performed it as a single agent in low tumor burden FL patients [55,90]. ABP798, the candidate of Amgen was evaluated in patients with grade I, II or IIIa FL and low tumor burden [49].…”
Section: Pharmacological Assessment Of Biosimilarity: Pk and Pd Comparative Studiesmentioning
confidence: 99%