Clinical Pharmacology & Biopharmaceutics
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A biosimilar is a successor to a biologic medicine that has lost patent protection or exclusivity. Due to their relative
complexity, biosimilars represent a separate regulatory class of medicines to small-molecule generics. Biosimilars are
biologics, and are approved via stringently defined regulatory pathways on the basis that they have demonstrated comparability
(high similarity) to their reference product. The introduction of biosimilars in the EU has already led to significant savings for
patients and payers. With many more such products at various stages of the development pipeline, the number of therapeutic
areas catered for by biosimilars will increase steadily over the next decade. The real benefit of biosimilars is the introduction of
genuine competition into an area that has historically been unhealthily short of it. Competition not only reduces prices; it also
frees up public funds to broaden overall access to healthcare. In addition, it provides a further incentive for the producers of
patent-protected medicines to come up with fresh ideas and genuinely original new products ? driving the ?virtuous circle? of
innovation. Biosimilar development requires substantial time and investment. A typical biosimilar takes 7-8 years to develop,
at a cost of between USD 75 and 250 million, with clinical trials that may involve about 500 patients. That compares to 8-10
years for a new drug application, at a cost of USD 800 million, including up to 1000 patients in clinical trials. For a smallmolecule
generic, by comparison, development may be completed in 2-3 years, at a cost of USD 2-3 million.
Ibrahim A Alsarra is the Professor of Pharmaceutics & Pharmaceutical Biotechnology, Department of Pharmaceutics, College of Pharmacy, King Saud University.
He has completed his PhD in Pharmaceutical Biotechnology and Drug Formulation Development, Division of Pharmaceutical Sciences, School of Pharmacy,
University Missouri-Kansas City, USA. He is the Deputy Director of Center of Excellence in Biotechnology Research. He is the President of Saudi Pharmaceutical
Society and the Editor-in-Chief of the Saudi Pharmaceutical Journal. He has published more than 80 papers in reputed journals and serving as an editorial board
member of a number of highly reputed international peer-reviewed journals.
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