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Biosimilar/ja: Difference between revisions

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'''バイオシミラー'''（'''biosimilar'''）（'''follow-on biologic'''または'''aftersequent entry biologic'''とも呼ばれる）とは、[[biopharmaceutical/ja|生物学的製剤]]であり、他社が製造する先発品とほぼ同一のコピーである。バイオシミラーとは、「イノベーター」である先発品の正式な承認版であり、先発品の[[chemical patent/ja|特許]]が切れた時点で製造が可能となる。イノベーター製品への言及は承認に不可欠な要素である。
{{Short description|Variant of a biopharmaceutical}}
A '''biosimilar''' (also known as '''follow-on biologic''' or '''subsequent entry biologic''') is a [[biopharmaceutical|biologic medical product]] that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's [[chemical patent|patent]] expires. Reference to the innovator product is an integral component of the approval.
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== さらに読む ==
== Further reading ==
* {{cite journal | vauthors = Udpa N, Million RP | title = Monoclonal antibody biosimilars | journal = Nature Reviews. Drug Discovery | volume = 15 | issue = 1 | pages = 13–4 | date = January 2016 | pmid = 26678619 | doi = 10.1038/nrd.2015.12 | s2cid = 27954836 }}
* {{cite journal | vauthors = Udpa N, Million RP | title = Monoclonal antibody biosimilars | journal = Nature Reviews. Drug Discovery | volume = 15 | issue = 1 | pages = 13–4 | date = January 2016 | pmid = 26678619 | doi = 10.1038/nrd.2015.12 | s2cid = 27954836 }}
* {{cite journal | vauthors = Jelkmann W | title = Biosimilar epoetins and other "follow-on" biologics: update on the European experiences | journal = American Journal of Hematology | volume = 85 | issue = 10 | pages = 771–80 | date = October 2010 | pmid = 20706990 | doi = 10.1002/ajh.21805 | s2cid = 205293428 | url = https://hal.archives-ouvertes.fr/hal-00552331/document | doi-access = free }}
* {{cite journal | vauthors = Jelkmann W | title = Biosimilar epoetins and other "follow-on" biologics: update on the European experiences | journal = American Journal of Hematology | volume = 85 | issue = 10 | pages = 771–80 | date = October 2010 | pmid = 20706990 | doi = 10.1002/ajh.21805 | s2cid = 205293428 | url = https://hal.archives-ouvertes.fr/hal-00552331/document | doi-access = free }}
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== 外部リンク ==
== External links ==
* [https://www.fda.gov/media/151058/download Overview of Biosimilar Products] U.S. [[Food and Drug Administration]]
* [https://www.fda.gov/media/151058/download Overview of Biosimilar Products] U.S. [[Food and Drug Administration]]
* [https://www.fda.gov/media/151061/download Biosimilar Regulatory Review and Approval ] U.S. [[Food and Drug Administration]]
* [https://www.fda.gov/media/151061/download Biosimilar Regulatory Review and Approval ] U.S. [[Food and Drug Administration]]
* [https://www.fda.gov/media/151094/download Interchangeable Biological Products ] U.S. [[Food and Drug Administration]]
* [https://www.fda.gov/media/151094/download Interchangeable Biological Products ] U.S. [[Food and Drug Administration]]
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{{Portal bar | Medicine}}
{{Portal bar | Medicine}}
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{{二次利用|date=7 March 2024}}
[[Category:Biopharmaceuticals]]
[[Category:Biopharmaceuticals]]
[[Category:Life sciences industry]]
[[Category:Life sciences industry]]
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