# Biosimilar Medicines: From Development Process to Marketing Authorization by the EMA and the FDA
## 7 Market Evaluation  
The EMA was the first regulatory authority to approve biosimilar medicines, in 2006. Since this was the first time that legislation and guidelines were developed to ensure the safe and effective approval of biosimilars, the EMA adopted a very cautious approach. The FDA only started approving biosimilar medicines in 2015, and since then, it has approved various biosimilars every year. Compared to the EMA, the FDA has a high approval rate, possibly due to the previous implementation of an approval pathway based on the legislative and expertise established by the EMA [1]. The number of biosimilar medicines approved by the EMA and the FDA per year are shown in Charts 1 and 2, respectively, from the approval of the first biosimilar medicine in 2006 to the present day. \begin{table}
\begin{tabular}{p{113.8 pt} p{113.8 pt} p{113.8 pt}} \hline \hline  & \multicolumn{1}{c}{**EMA**} & \multicolumn{1}{c}{**FDA**} \\ \hline \multicolumn{2}{p{113.8 pt}}{**Approval Process**} & Centralized procedure & Section 351(k) of the PHSA \\ \hline \multirow{2}{*}{**Scope**} & Valid at regional level, covering all 27 Member States of the EU and the countries of the EEA, Norway and Iceland. & Valid nationally, only within the US. \\ \hline \multirow{2}{*}{**Teams Involved**} & BMWP, CHMP and PRAC. & CBER, CDER and OTBB. \\ \hline \multirow{6}{*}{**Main Steps of the Evaluation**} & Pre-submission; assessment; Preparation of responses; Assessment of responses; Preparation of responses; Assessment of responses; Preparation of responses; Final CHMP opinion; Final EC decision. & Pre-submission activities; Process submission; Plan the review of the application; Product scientific/regulatory review; Official action on the application; Post-decision feedback. \\ \hline \multirow{6}{*}{**Steps After the Evaluation**} & Transmission of Opinion and Annexes in all EU languages to Applicent, Commission, members of the Standing Committee, Norway and Iceland; EMA issues press releases and updates its official website to inform about the approval. & The final decision is communicated to all team members and to the applicent; The biosimilar is included in the Purple Book. \\ \hline \multirow{2}{*}{**Time**} & 210 “active” days + periods when the clock is stopped. & About 10 months (\(\sim\)300 days). \\ \hline \hline \end{tabular}
\end{table} 
Table 7: Comparison between relevant aspects of the approval process for biosimilar medicines by the EMA and the FDA. The first biosimilar approved by the EMA was Omnitrope(r) in 2006, whose reference medicine is Genotropin(r), which is a human growth hormone (hGH), that contains somatoropin as active substance and belongs to the pituitary and hypothalamic hormone and analogue pharmaceutical group. The most recently approved biosimilar medicine was Wezenla(r) in 2024, whose reference medicine is Stelara(r), which is a monoclonal antibody that contains ustekinumab as the active substance and belongs to the immunosuppressant pharmaceutical group [110]. In the case of the FDA, the first biosimilar approved was Zarxio(r) in 2015, which is a granulocyte colony-stimulating factor (G-CSF), whose reference medicine is Neupogen(r), that contains filgrastim as the active substance and belongs to the immunostimulant pharmaceutical group. The most recently approved biosimilar medicine was Epysqli(r) in 2024, which is a monoclonal antibody, whose reference medicine is Soliris(r), that contains eculizumab as the active substance and belongs to the immunosuppressant pharmaceutical group [111]. In 2021, the FDA approved the first interchangeable biosimilar, called Semgle(r), whose active substance is insulin glargine. This product can be substituted for its reference medicine, Lantus(r), at the pharmacy level without the intervention of the prescribing healthcare provider [111]. Until today, a wide variety of biosimilar medicines have already received regulatory approval and are available on the market.