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Biosimilars production in Africa opportunities & challenges.
Abdel-Maged, Amany E; Mikhaeil, Margrit F; Elkordy, Ahmed I; Gad, Amany M; Elshazly, Mohamed M.
Afiliação
  • Abdel-Maged AE; Egyptian Drug Authority (EDA), Cairo, Egypt.
  • Mikhaeil MF; Associate Scientist, Quality Control Department, Jnj Leiden, Netherlands.
  • Elkordy AI; Regulatory Affairs & Vaccines Unit Director, BGP, Cairo, Egypt.
  • Gad AM; Egyptian Drug Authority (EDA), Cairo, Egypt; Department of Pharmacology and Toxicology, Faculty of Pharmacy, Sinai University, Kantara Branch, Ismailia, Egypt, Zip code: 41636. Electronic address: amany.gad@su.edu.eg.
  • Elshazly MM; Department of Pharmacognosy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.
Regul Toxicol Pharmacol ; 149: 105626, 2024 May.
Article em En | MEDLINE | ID: mdl-38636774
ABSTRACT
The healthcare systems of African nations heavily rely on importing and repackaging biological medicine. More than 70% of the pharmaceutical products consumed in Africa are imported. The localization of biosimilar production can have a positive impact on the availability and cost of these products by reducing the expenses for African governments and making essential healthcare products more accessible to the population. However, it is evident that the developing countries, particularly African nations, face various obstacles and difficulties in localizing biosimilar production. These challenges encompass development, manufacturing, evaluation, and registration processes. In this review, we will highlight the significant hurdles and achievements encountered during the localization process of biosimilars.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Medicamentos Biossimilares País como assunto: Africa Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Medicamentos Biossimilares País como assunto: Africa Idioma: En Ano de publicação: 2024 Tipo de documento: Article