Biosimilars - BioRiver
Biosimilars - BioRiver
Biosimilars - BioRiver
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Benefit on Early Detailed Characterization<br />
[…] a reduction in the data requirements is possible for biosimilars, the prelicensing<br />
data package is nevertheless substantial. Similarity in physicochemical<br />
characteristics is a prerequisite for a possible reduction in nonclinical and clinical<br />
data requirements.<br />
The amount of possible data reduction depends on how well the molecule can<br />
be characterized by state-of-the-art analytical methods, on observed or<br />
potential differences between the biosimilar and the reference product, and the<br />
clinical experience gained with the reference product and/or the substance class […].<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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