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Rodríguez, Carlos del Castillo
- Requirements for Biosimilar Authorization: A Legal and Comparative Perspective – FDA Versus EMA
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Authors
Affiliations
1 Pharmacy Military Centre of Defence. Logistic Base San Pedro, Highway M-609 Miraflores, km 34, E-28770, Colmenar Viejo (Madrid), ES
2 Universidad Complutense de Madrid, History of Pharmacy and Pharmaceutical Legislation, Department of Galenic Pharmacy and Food Technology. Ramon y Cajal Square s/n, E-28040, Madrid (Madrid), ES
1 Pharmacy Military Centre of Defence. Logistic Base San Pedro, Highway M-609 Miraflores, km 34, E-28770, Colmenar Viejo (Madrid), ES
2 Universidad Complutense de Madrid, History of Pharmacy and Pharmaceutical Legislation, Department of Galenic Pharmacy and Food Technology. Ramon y Cajal Square s/n, E-28040, Madrid (Madrid), ES
Source
Current Science, Vol 120, No 1 (2021), Pagination: 56-65Abstract
Both European Medicines Agency (EMA) and Food and Drug Administration (FDA) have developed a regulatory framework for the authorization of biosimilar medicines. Marketing authorization application must demonstrate that the biosimilar proposed has similar physicochemical, biological, clinical and non-clinical profiles to a reference biological medicine, which could be marketed upon expiration of the patent and data protection period of the innovative medicine. Although the basic principles to demonstrate biosimilarity are equivalent, there are significant differences in certain aspects. The biosimilarity criteria have not remained static, observing a reduction in the regulatory requirements established by EMA. On the other hand, several proposals concerning the amendment of biosimilarity demonstration have been suggested.Keywords
Authorization, Biosimilar Medicines, Legal Perspective, Regulatory Framework.Full Text
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