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Requirements for Biosimilar Authorization: A Legal and Comparative Perspective – FDA Versus EMA


Affiliations
1 Pharmacy Military Centre of Defence. Logistic Base San Pedro, Highway M-609 Miraflores, km 34, E-28770, Colmenar Viejo (Madrid), Spain
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), Spain
 

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.
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  • Requirements for Biosimilar Authorization: A Legal and Comparative Perspective – FDA Versus EMA

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Authors

Alfonso Noguera Peña
Pharmacy Military Centre of Defence. Logistic Base San Pedro, Highway M-609 Miraflores, km 34, E-28770, Colmenar Viejo (Madrid), Spain
Carlos del Castillo Rodríguez
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), Spain

Abstract


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.

References





DOI: https://doi.org/10.18520/cs%2Fv120%2Fi1%2F56-65