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

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.