Biosimilars - BioRiver
Biosimilars - BioRiver
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