Supporting biosimilarity and extrapolation

Supporting biosimilarity and extrapolation

With many biosimilars being approved around the world, there is an urgent need for clear guidelines on establishing biosimilarity and on approving subsequent extrapolation. The balance between clinical studies and analytics in establishing and confirming biosimilarity are discussed in this paper. Ke...

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Veröffentlicht in:GaBI Journal 2015-12, Vol.4 (4), p.180-183
1. Verfasser: Perks, Bea
Format: Artikel
Sprache:eng
Schlagworte:
Medical research
Medicine, Experimental
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Beschreibung
Zusammenfassung:With many biosimilars being approved around the world, there is an urgent need for clear guidelines on establishing biosimilarity and on approving subsequent extrapolation. The balance between clinical studies and analytics in establishing and confirming biosimilarity are discussed in this paper. Keywords: Analytics, biosimilarity, clinical studies, extrapolation
ISSN:2033-6403
2033-6772
DOI:10.5639/gabij.2015.0404.041