A biosimilar is a biologic product that is highly similar to a licensed biologic (ââ?¬Å?originatorââ?¬Â) such that there are no clinically\nmeaningful differences in safety, purity, or potency between the biosimilar and the originator. As patent protection and data\nexclusivity for the biologic rituximab expire, several potential biosimilars to rituximab are in development, which could soon lead to\nthe availability of numerous rituximab biosimilars. Biosimilars are evaluated using thorough and rigorous analyses of the potential\nbiosimilar versus the originator biological to confirm similar structure, function, and clinical efficacy as well as safety. Approval of\na biosimilar is based upon the totality of the evidence demonstrating similarity to the originator. An understanding of the process\nof the interchangeable designation of a biosimilar is important in the context of patient outcomes. We conducted an analysis of\nthe properties and benefits of rituximab in the treatment of inflammatory diseases, the development and approval of biosimilars,\nand the potential benefits of rituximab biosimilars. PubMed and ClinicalTrials.gov databases were searched for ââ?¬Å?biosimilarââ?¬Â and\nââ?¬Å?rituximabââ?¬Â and regulatory and pharmaceutical company web pages were screened regarding biosimilars in development and\nspecific guidelines developed for the approval of biosimilars.The results indicate that, at present, six rituximab biosimilar candidates\nare undergoing comparative clinical development, and two were recently approved in the European Union. Our analysis indicates\nrituximab biosimilars are expected to have a continuing role in treating inflammatory conditions such as rheumatoid arthritis.
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