Cargando…
Challenges Faced by the Biopharmaceutical Industry in the Development and Marketing Authorization of Biosimilar Medicines in BRICS-TM Countries: An Exploratory Study
BACKGROUND: Biosimilars are expected to emerge as a rapidly growing segment of the biopharmaceutical industry. However, the biosimilar industry faces multiple challenges and obstacles in developing and marketing these complex products. Divergent regulatory framework in emerging countries adds to rep...
Autores principales: | Rahalkar, Hasumati, Sheppard, Alan, Lopez-Morales, Carlos Augusto, Lobo, Luciano, Salek, Sam |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8295548/ https://www.ncbi.nlm.nih.gov/pubmed/34292558 http://dx.doi.org/10.1007/s40290-021-00395-8 |
Ejemplares similares
-
Comparison of BRICS-TM Countries' Biosimilar Regulatory Frameworks With Australia, Canada and Switzerland: Benchmarking Best Practices
por: Rahalkar, Hasumati, et al.
Publicado: (2021) -
Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities
por: Rahalkar, Hasumati, et al.
Publicado: (2021) -
Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines
por: Rahalkar, Hasumati, et al.
Publicado: (2018) -
Approval of the first biosimilar antibodies in Europe: A major landmark for the biopharmaceutical industry
por: Beck, Alain, et al.
Publicado: (2013) -
The Market of Biopharmaceutical Medicines: A Snapshot of a Diverse Industrial Landscape
por: Moorkens, Evelien, et al.
Publicado: (2017)