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2018 ; 2018
(ä): 3762864
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Biosimilars Have Arrived: Rituximab
#MMPMID29765782
Greenwald M
; Tesser J
; Sewell KL
Arthritis
2018[]; 2018
(ä): 3762864
PMID29765782
show ga
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 screened
regarding biosimilars in development and specific guidelines developed for the
approval of biosimilars. The results indicate that, at present, six rituximab
biosimilar candidates are undergoing comparative clinical development, and two
were recently approved in the European Union. Our analysis indicates rituximab
biosimilars are expected to have a continuing role in treating inflammatory
conditions such as rheumatoid arthritis.