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)

• Published in: BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy Vol. 34; no. 2; pp. 171 - 181
• Main Authors: Sharman, Jeff P., Liberati, Anna Marina, Ishizawa, Kenichi, Khan, Tahira, Robbins, Jeffery, Alcasid, Ann, Rosenberg, Julie Ann, Aurer, Igor
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.04.2020; Springer Nature B.V
• Subjects: Adult; Aged; Aged, 80 and over; Antibodies; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - pharmacokinetics; Antineoplastic Agents - pharmacology; Antineoplastic Agents - therapeutic use; Autoimmune diseases; Biological products; Biomedical and Life Sciences; Biomedicine; Biosimilar Pharmaceuticals - adverse effects; Biosimilar Pharmaceuticals - pharmacokinetics; Biosimilar Pharmaceuticals - pharmacology; Biosimilar Pharmaceuticals - therapeutic use; Cancer Research; CD20 antigen; Chemotherapy; Double-Blind Method; Double-blind studies; Drug dosages; FDA approval; Female; Humans; Immunogenicity; Immunoglobulins; Immunotherapy; Internet resources; Lymphoma; Lymphoma, Follicular - drug therapy; Male; Middle Aged; Molecular Medicine; Monoclonal antibodies; Oncology; Original; Original Research Article; Pharmacodynamics; Pharmacokinetics; Pharmacotherapy; Regulatory approval; Rituximab; Rituximab - adverse effects; Rituximab - pharmacokinetics; Rituximab - pharmacology; Rituximab - therapeutic use; Safety; Studies; Targeted cancer therapy; Therapeutic Equivalency; United States > US

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, pharmacokineti...