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Biosimilars - BioRiver

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Biosimilar Definition<br />

“A biosimilar is a copy version of an already<br />

authorized biological medicinal product with<br />

demonstrated similarity in physicochemical<br />

characteristics, efficacy and safety, based on<br />

a comprehensive comparability exercise.”<br />

Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP)<br />

of the Committee for Medicinal Products for Human Use (CHMP), EMA<br />

Martina Weise et al.<br />

Nature Biotechnology 29 (8) August 2011

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