Abstract
Biosimilars that were not compared in clinical trials with the compound innovator are not true biosimilars (biocopies) and are associated with risks that the clinical rheumatologist should be aware of before generalized use. This article comments on various aspects surrounding the use of such biocopies in clinical rheumatology.
MeSH terms
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Antibodies, Monoclonal / therapeutic use
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Antirheumatic Agents / standards*
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Antirheumatic Agents / therapeutic use
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Arthritis, Rheumatoid / drug therapy
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Biological Products / standards
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Biological Products / therapeutic use
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Biosimilar Pharmaceuticals / standards*
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Biosimilar Pharmaceuticals / therapeutic use
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Drug Approval / legislation & jurisprudence
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Humans
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Infliximab
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Patents as Topic* / legislation & jurisprudence
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Tumor Necrosis Factor-alpha / antagonists & inhibitors*
Substances
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Antibodies, Monoclonal
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Antirheumatic Agents
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Biological Products
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Biosimilar Pharmaceuticals
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Tumor Necrosis Factor-alpha
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Infliximab