Title: Biosimilars: controversies as illustrated by rhGH
Authors: Declerck, Paul ×
Darendeliler, Feyza
Goth, Miklos
Kolouskova, Stanislava
Micle, Ioana
Noordam, Cees
Peterkova, Valentina
Volevodz, Natalia N
Zapletalova, Jirina
Ranke, Michael B #
Issue Date: May-2010
Publisher: Librapharm/informa healthcare
Series Title: Current medical research and opinion vol:26 issue:5 pages:1219-1229
Abstract: Background and scope:
Similar biological medicinal products, also called ‘biosimilars’, are copies of biopharmaceutical products whose patent has expired. Whether biosimilars are truly comparable and interchangeable with their reference biopharmaceutical products in terms of quality, efficacy and tolerability, is still a matter of debate. This review discusses the controversies related to the criteria for regulatory approval of biosimilars. These concerns are illustrated using recombinant human growth hormone (rhGH) biosimilars
as an example.
ISSN: 0300-7995
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Laboratory for Pharmaceutical Biology (-)
× corresponding author
# (joint) last author

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