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A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways.

Authors :
Druedahl, Louise C.
Almarsdóttir, Anna Birna
Kälvemark Sporrong, Sofia
De Bruin, Marie Louise
Hoogland, Hans
Minssen, Timo
van de Weert, Marco
Kesselheim, Aaron S.
Sarpatwari, Ameet
Source :
Nature Biotechnology; Nov2020, Vol. 38 Issue 11, p1253-1256, 4p
Publication Year :
2020

Abstract

Abbreviated regulatory approval pathways for biosimilars were created to accommodate intellectual property protection, foster competition and lower drug prices, but their success in achieving these goals has been mixed. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
10870156
Volume :
38
Issue :
11
Database :
Complementary Index
Journal :
Nature Biotechnology
Publication Type :
Academic Journal
Accession number :
146808139
Full Text :
https://doi.org/10.1038/s41587-020-0717-7