The advent of biosimilar therapies in rheumatology--"O brave new world"
UMass Chan Affiliations
Department of Medicine, Division of RheumatologyDocument Type
Journal ArticlePublication Date
2012-06-05Keywords
Antirheumatic AgentsBiosimilar Pharmaceuticals
Drug Approval
Drug Substitution
Humans
Rheumatic Diseases
Rheumatology
*Therapeutic Equivalency
Complex Mixtures
Musculoskeletal Diseases
Rheumatology
Skin and Connective Tissue Diseases
Metadata
Show full item recordAbstract
Patents for many key biological agents will soon expire. Third-party companies are, therefore, in the process of developing their own versions, termed biosimilar agents, of these innovator products. However, manufacture of biosimilar agents is complicated by the requirement for their production in biological systems, small variations in which can influence the structure, activity and metabolism of the biosimilar product. The development of biosimilar therapies for the treatment of patients with rheumatic diseases could potentially result in substantial cost savings for patients and health care providers, and consequently, increased availability of effective therapies. However, legislation that regulates the manufacture, registration and approval of biosimilar therapies varies considerably between different countries. In addition, major safety and efficacy concerns must be addressed before a rheumatologist can routinely substitute an innovator pharmaceutical with a biosimilar product.Source
Nat Rev Rheumatol. 2012 Jun 5;8(7):430-6. doi: 10.1038/nrrheum.2012.84. Link to article on publisher's siteDOI
10.1038/nrrheum.2012.84Permanent Link to this Item
http://hdl.handle.net/20.500.14038/48721PubMed ID
22664834Related Resources
Link to Article in PubMedae974a485f413a2113503eed53cd6c53
10.1038/nrrheum.2012.84