# Biosimilar Medicines: From Development Process to Marketing Authorization by the EMA and the FDA
## 3 Biosimilar Medicines Regulatory Framework  
The emergence of biosimilar medicines revolutionized the pharmaceutical market by offering biological products at a much more affordable price. To guarantee the safety, efficacy and quality of these medicines, regulations and procedures for the development and approval of these products were established [25]. The EMA and the FDA are the world's largest regulatory entities, which are responsible for this assessment in the European Union (EU) and in the US, respectively. These two agencies have a great global influence and are recognized for the rigor of their regulatory and approval processes. The EMA pioneered in the regulation of biosimilar medicines and created several guidelines, presented in Table 2, related to the development and approval of these products to clarify certain aspects and to ensure that they were produced in accordance with the required safety, quality and efficacy criteria. Some guidelines are more general and compile all the relevant information about these medicines and others are more specific for each type of biosimilar [26; 27]. \begin{table}
\begin{tabular}{p{113.8 pt} p{284.5 pt}} \hline \hline
**Topic** & **Title** \\ \hline Tailored clinical approach for biosimilars & Concept paper for the development of a reflection paper on a tailored clinical approach in biosimilar development. \\ \hline \multirow{4}{*}{\begin{tabular}{} \end{tabular} } & Similar biological medicinal products. \\  & Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. \\  & Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. \\ \hline \multirow{4}{*}{\
\begin{tabular}{} \end{tabular} } & Biosimilar medicinal products containing recombinant granulocyte-colony stimulating factor. \\  & Non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues. \\  & Similar biological medicinal products containing interferon beta. \\  & Similar biological medicinal products containing monoclonal antibodies: non-clinical and clinical issues. \\  & Similar biological medicinal products containing recombinant erythropoiesis. \\  & Similar biological medicinal products containing recombinant follicle-stimulating hormone. \\  & Similar medicinal products containing somatropin. \\  & Reflection paper: Non-clinical and clinical development of similar medicinal products containing recombinant Interferon Alfa. \\ \hline \multirow{4}{*}{
\begin{tabular}{} \end{tabular} } & Comparability of biotechnology-derived medicinal products after a change in the manufacturing process—non-clinical and clinical issues. \\  & Immunogenicity assessment of biotechnology-derived therapeutic proteins. \\ \cline{1-1}  & Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use. \\ \cline{1-1}  & Biosimilars—What are the key pharmacokinetic considerations in the assessment of biosimilarity? \\ \hline \hline \end{tabular}
\end{table} 
Table 2: European scientific guidelines for biosimilar medicines [28]. A few years later, the FDA started to create a set of guidance documents, presented in Table 3, for the development, approval and marketing of biosimilar medicines, in order to provide regulatory clarity and guidance to manufacturers. However, unlike the EMA, the FDA has developed general guidance documents that allow for a tailored approach to each product [29]. In 2018, the FDA published the Biosimilar Action Plan (BAP), whose main objective was to provide regulatory clarity to improve the development and approval procedures for biosimilar medicines and simplify the concept for patients and healthcare professionals by providing educational assistance and consequently increase their trust in this type of product [31].