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Clinical data requirements for biosimilars in the EU: immunogenicity comparability

04:54 EST 8 Nov 2019 | Generics and Biosimilars Initiative

The totality of evidence approach for biosimilars in the European Union (EU) was discussed in a review paper [1] using case studies to illustrate biosimilars for which differences were observed in different parts of the comparability exercise and the justification for why these differences did not preclude regulatory approval.

Original Article: Clinical data requirements for biosimilars in the EU: immunogenicity comparability

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