Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009-2022.

Kuribayashi, Ryosuke; Nakano, Ayuki; Hariu, Aya; Kishioka, Yasuhiro; Honda, Futaba

Kuribayashi, Ryosuke; Nakano, Ayuki; Hariu, Aya; Kishioka, Yasuhiro; Honda, Futaba.

Afiliação

Kuribayashi R; Office of Cellular and Tissue-Based Products Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan. kuribayashi-ryosuke@pmda.go.jp.
Nakano A; Office of Cellular and Tissue-Based Products Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
Hariu A; Office of Cellular and Tissue-Based Products Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
Kishioka Y; Office of Cellular and Tissue-Based Products Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
Honda F; Office of Cellular and Tissue-Based Products Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.

BioDrugs ; 37(4): 443-451, 2023 Jul.

Article em En | MEDLINE | ID: mdl-37227657

Assuntos

Medicamentos Biossimilares; Humanos; Estados Unidos; Medicamentos Biossimilares/efeitos adversos; Japão; Europa (Continente); Aprovação de Drogas

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Guideline Limite: Humans País/Região como assunto: America do norte / Asia / Europa Idioma: En Ano de publicação: 2023 Tipo de documento: Article

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