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- Title
How similar do 'biosimilars' need to be?
- Authors
Schellekens, Huub
- Abstract
The article comments on the requirements for a marketing authorization for biosimilars, an alternative term for biogenerics. The R&D industry claims that patient safety demands clinical and safety studies for every indication claimed; the generics industry counters that simple comparisons of bioequivalence on the basis of surrogate markers for clinical efficacy is adequate. Even if the biosimilar product has the same gene sequence, vector, host cell line, culture conditions and purification methods as the innovative protein, it can still differ substantially in its biological and clinical properties.
- Subjects
GENERIC drugs; PHARMACEUTICAL industry; GENERIC products; CELL lines; GENES; CELL culture
- Publication
Nature Biotechnology, 2004, Vol 22, Issue 11, p1357
- ISSN
1087-0156
- Publication type
Article
- DOI
10.1038/nbt1104-1357