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

Louise C Druedahl; Anna Birna Almarsdóttir; Sofia Kälvemark Sporrong; Marie Louise De Bruin; Hans Hoogland; Timo Minssen; Marco van de Weert; Aaron S Kesselheim; Ameet Sarpatwari

doi:10.1038/s41587-020-0717-7

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

Louise C Druedahl, Anna Birna Almarsdóttir, Sofia Kälvemark Sporrong, Marie Louise De Bruin, Hans Hoogland, Timo Minssen, Marco van de Weert, Aaron S Kesselheim, Ameet Sarpatwari^*

^*Corresponding author for this work

Research output: Contribution to journal › Journal article › Research › peer-review

11 Citations (Scopus)

Original language	English
Journal	Nature Biotechnology
Volume	38
Issue number	11
Pages (from-to)	1253-1256
Number of pages	4
ISSN	1087-0156
DOIs	https://doi.org/10.1038/s41587-020-0717-7
Publication status	Published - 2020

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10.1038/s41587-020-0717-7

Forsker: Jura står i vejen for biosimilært potentiale
Louise C. Druedahl
19/03/2021
1 Media contribution
Press/Media: Press / Media
Scientific, legal and regulatory challenges facing biosimilars development
Louise C. Druedahl
11/12/2020
1 Media contribution
Press/Media: Press / Media

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Druedahl, L. C., Almarsdóttir, A. B., Kälvemark Sporrong, S., De Bruin, M. L., Hoogland, H., Minssen, T., van de Weert, M., Kesselheim, A. S., & Sarpatwari, A. (2020). A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways. Nature Biotechnology, 38(11), 1253-1256. https://doi.org/10.1038/s41587-020-0717-7

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

In: Nature Biotechnology, Vol. 38, No. 11, 2020, p. 1253-1256.

Research output: Contribution to journal › Journal article › Research › peer-review

Druedahl, LC , Almarsdóttir, AB , Kälvemark Sporrong, S, De Bruin, ML, Hoogland, H, Minssen, T , van de Weert, M, Kesselheim, AS & Sarpatwari, A 2020, 'A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways', Nature Biotechnology, vol. 38, no. 11, pp. 1253-1256. https://doi.org/10.1038/s41587-020-0717-7

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. / A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways. In: Nature Biotechnology. 2020 ; Vol. 38, No. 11. pp. 1253-1256.

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

Access to Document

Press/Media

Forsker: Jura står i vejen for biosimilært potentiale

Scientific, legal and regulatory challenges facing biosimilars development

Cite this