How Similar do Biosimilars Need to be?  

Oleh:

Schellekens, Huub

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Nature Biotechnology: The Science and Business of Biotechnology vol. 22 no. 11 (Nov. 2004), page 1357-1359.
Topik: SIMILARITY; similar; biosimilars

Ketersediaan

Perpustakaan Pusat (Semanggi) Nomor Panggil: NN9.3 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

A fierce debate is currently underway concerning the requirements for a marketing authorization for biosimilars an alternative term for biogenerics recently formally introduced into the drug development lexicon in two guidelines from the european medicine agency's (EMEA : London) committee for preproetary medicinal products (CPMP). Unlike small molecules, protein drugs are not produced by chemical syntheses but by cells in culture or whole organisms, which are inherently more variable. The assessment of the bioequivalence of a protein produced by two different manufacturers thus presents a much greater challenge to regulators....

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