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Biosimilars: how similar?
Author(s) -
Strand V.,
Cronstein B.
Publication year - 2014
Publication title -
internal medicine journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.596
H-Index - 70
eISSN - 1445-5994
pISSN - 1444-0903
DOI - 10.1111/imj.12292
Subject(s) - biosimilar , medicine , biological drugs , drug approval , quality (philosophy) , intensive care medicine , risk analysis (engineering) , pharmacology , immunology , rheumatoid arthritis , drug , philosophy , epistemology
As patents expire on biological agents for the treatment of rheumatic diseases, we have the opportunity to develop non‐proprietary biologic agents, biosimilars. The development and approval of these agents present novel challenges to both pharma and regulatory agencies although there is great promise of high quality, less expensive biologic agents for the treatment of rheumatic diseases. Here, we review the definitions of biosimilars, the regulatory challenges to approval of these agents and the record of approvals of biosimilars to date.