Literature DB >> 33144720

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

Louise C Druedahl1,2, Anna Birna Almarsdóttir2, Sofia Kälvemark Sporrong2,3, Marie Louise De Bruin1,4, Hans Hoogland5, Timo Minssen6, Marco van de Weert7, Aaron S Kesselheim8, Ameet Sarpatwari9.   

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Year:  2020        PMID： 33144720     DOI： 10.1038/s41587-020-0717-7

Source DB:  PubMed          Journal:  Nat Biotechnol        ISSN： 1087-0156            Impact factor:   54.908


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  2 in total

1.  Evolving Biosimilar Clinical Requirements: A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators.

Authors:  Louise C Druedahl; Sofia Kälvemark Sporrong; Marco van de Weert; Marie Louise De Bruin; Hans Hoogland; Timo Minssen; Anna Birna Almarsdóttir
Journal:  BioDrugs       Date:  2021-04-08       Impact factor: 5.807

2.  Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution.

Authors:  Louise C Druedahl; Sofia Kälvemark Sporrong; Timo Minssen; Hans Hoogland; Marie Louise De Bruin; Marco van de Weert; Anna Birna Almarsdóttir
Journal:  PLoS One       Date:  2022-01-11       Impact factor: 3.240
  2 in total

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