Evaluating imbalances of adverse events during biosimilar development.
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ABSTRACT:
SUBMITTER: Vana AM
PROVIDER: S-EPMC4968111 | biostudies-literature | 2016 Jul
REPOSITORIES: biostudies-literature
Publications
Evaluating imbalances of adverse events during biosimilar development.
Vana Alicia M AM Freyman Amy W AW Reich Steven D SD Yin Donghua D Li Ruifeng R Anderson Scott S Jacobs Ira A IA Zacharchuk Charles M CM Ewesuedo Reginald R
mAbs 20160406 5
Biosimilars are designed to be highly similar to approved or licensed (reference) biologics and are evaluated based on the totality of evidence from extensive analytical, nonclinical and clinical studies. As part of the stepwise approach recommended by regulatory agencies, the first step in the clinical evaluation of biosimilarity is to conduct a pharmacokinetics similarity study in which the potential biosimilar is compared with the reference product. In the context of biosimilar development, a ...[more]
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