Similar biologics in India: A story of access or potential for compromise?

Jois, Ramesh; Mukherjee, Sukumar; Rajeswari, S; Rath, P D; Goyal, Vishal; Gupta, Disha

Jois, Ramesh; Mukherjee, Sukumar; Rajeswari, S; Rath, P D; Goyal, Vishal; Gupta, Disha.

Afiliação

Jois R; Department of Rheumatology & Clinical Immunology, Vikram Hospital, Bengaluru, Karnataka, India.
Mukherjee S; Department of Rheumatology, GD Hospital & Diabetes Institute, Kolkata, West Bengal, India.
Rajeswari S; Department of Rheumatology, Madras Medical College, Chennai, Tamil Nadu, India.
Rath PD; Department of Rheumatology, Max Super Specialty Hospital, New Delhi, India.
Goyal V; Medical Affairs, Janssen, Johnson & Johnson Pvt. Ltd., Mumbai, Maharashtra, India.
Gupta D; Medical Affairs, Janssen, Johnson & Johnson Pvt. Ltd., Mumbai, Maharashtra, India.

Indian J Med Res ; 152(5): 456-467, 2020 Nov.

Article em En | MEDLINE | ID: mdl-33707387

Assuntos

Medicamentos Biossimilares; Anticorpos Monoclonais/uso terapêutico; Medicamentos Biossimilares/uso terapêutico; Humanos; Índia

Palavras-chave

Biopharmaceuticals; India; biosimilars; immunogenicity; large molecules; pharmacovigilance; potency; regulatory guidelines; similar biologics

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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Medicamentos Biossimilares Tipo de estudo: Guideline Limite: Humans País/Região como assunto: Asia Idioma: En Revista: Indian J Med Res Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Índia

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