Of action. This is often an iterative process in which analytical similarity is tested and then further explored in preclinical biofunctional tests to determine whether minor differences, should they exist, result in differences in the biological activity of the molecule (Fig. 1). Confidence in the similarity of the molecule at this foundational step allows for a reduction in residual uncertainty

Of action. This is often an iterative process in which analytical similarity is tested and then further explored in preclinical biofunctional tests to determine whether minor differences, should they exist, result in differences in the biological activity of the molecule (Fig. 1). Confidence in the similarity of the molecule at this foundational step allows for a reduction in residual uncertainty

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An DD, Ho V, Meibohm B, et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals. 2014;42(4):177?3. Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood. 2014;124(22): 3191?. Ebbers HC. Biosimilars: in support of extrapolation of indications. J Crohns Colitis. 2014;8(5):431?. Liu J, et al. Assessing analytical si

An DD, Ho V, Meibohm B, et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals. 2014;42(4):177?3. Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood. 2014;124(22): 3191?. Ebbers HC. Biosimilars: in support of extrapolation of indications. J Crohns Colitis. 2014;8(5):431?. Liu J, et al. Assessing analytical si

An DD, Ho V, Meibohm B, et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals. 2014;42(4):177?3. Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood. 2014;124(22): 3191?. Ebbers HC. Biosimilars: in support of extrapolation of indications. J Crohns Colitis. 2014;8(5):431?. Liu J, et al. Assessing analytical si

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