Biosimilars Have Arrived: Rituximab

Arthritis
Maria GreenwaldK Lea Sewell

Abstract

A biosimilar is a biologic product that is highly similar to a licensed biologic ("originator") such that there are no clinically meaningful differences in safety, purity, or potency between the biosimilar and the originator. As patent protection and data exclusivity for the biologic rituximab expire, several potential biosimilars to rituximab are in development, which could soon lead to the availability of numerous rituximab biosimilars. Biosimilars are evaluated using thorough and rigorous analyses of the potential biosimilar versus the originator biological to confirm similar structure, function, and clinical efficacy as well as safety. Approval of a biosimilar is based upon the totality of the evidence demonstrating similarity to the originator. An understanding of the process of the interchangeable designation of a biosimilar is important in the context of patient outcomes. We conducted an analysis of the properties and benefits of rituximab in the treatment of inflammatory diseases, the development and approval of biosimilars, and the potential benefits of rituximab biosimilars. PubMed and ClinicalTrials.gov databases were searched for "biosimilar" and "rituximab" and regulatory and pharmaceutical company web pages were s...Continue Reading

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May 11, 2019·Multiple Sclerosis : Clinical and Laboratory Research·Brandon P Moss, Jeffrey A Cohen
Jun 9, 2019·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Jichun YangFeng Sun
Sep 10, 2019·Expert Opinion on Biological Therapy·Ju-Yang JungChang-Hee Suh
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Oct 24, 2020·Brain Sciences·Despoina FlorouVasso Apostolopoulos

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