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Clinical and Regulatory Perspectives on Biosimilar Therapies and Intended Copies of Biologics in Rheumatology
Rheumatology International (02/27/2016) Mysler, E.; Pineda, C.; Horiuchi, T.
A recent study looked at biosimilar therapies and intended copies of biologic drugs for the treatment of rheumatological conditions. Whereas a biosimilar has been proven to be similar to the originator biologic in terms of safety and efficacy and to have no clinically meaningful differences, an "intended copy" is a copy of an originator biologic that has not undergone thorough comparative evaluations but is being commercialized in some regions. The researchers note that more information is needed regarding intended copies compared with the originator product, as they may have clinically significant differences in terms of formulation, dosages, efficacy, or safety.
Abstract News © 2016 INFORMATION, INC.
