The State of the Art in the Development of Biosimilars

The development of biologic therapeutics using advanced technology to copy and improve on nature's design of complex peptides, proteins, and glycoproteins has enabled the treatment of diseases in entirely new ways and brought unique and lifesaving treatments to many people. However, at least in...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2012-03, Vol.91 (3), p.405-417
Main Authors: McCamish, Mark, Woollett, Gillian
Format: Article
Language:English
Subjects:
Animals
Biological and medical sciences
Biosimilar Pharmaceuticals - standards
Biotechnology - legislation & jurisprudence
Biotechnology - methods
Cost-Benefit Analysis
Drug and Narcotic Control - legislation & jurisprudence
Drug Industry - legislation & jurisprudence
Europe
Health Services Needs and Demand
Humans
Medical sciences
Patents as Topic
Pharmacology. Drug treatments
United States
United States Food and Drug Administration
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Summary:The development of biologic therapeutics using advanced technology to copy and improve on nature's design of complex peptides, proteins, and glycoproteins has enabled the treatment of diseases in entirely new ways and brought unique and lifesaving treatments to many people. However, at least in part because of cost pressures, access to these truly amazing products has not been uniformly available; many patients do not qualify for these treatments, or the treatment is postponed until disabilities accumulate. The development of biosimilars—essentially copies of the original biologic drugs after patent expiration—allows for wider and, as important, earlier access to these agents because of their lower cost and consequently greater affordability. The development and commercialization of biosimilars can help address unmet medical needs by improving access to well‐established therapeutic interventions while improving health‐care affordability. Clinical Pharmacology & Therapeutics (2012); 91 3, 405–417. doi:10.1038/clpt.2011.343
ISSN:0009-9236
1532-6535
DOI:10.1038/clpt.2011.343