# FDA Approvals of Biologics in 2022
## 4 Therapeutic Indications and Mechanisms of Action
### Autoimmune Conditions  
The second type of disease most targeted by the approved Biologics in 2022 is autoimmune conditions (Table 4). Spevigo(tm) (spesolimab) has been approved this year to treat generalized pustular psoriasis (GPP), a rare and autoinflammatory condition that can strike both children and adults, affecting more Asians than other population groups [60]. To date, there is no standard treatment specifically for GPP, therapeutic strategies being limited to the use of synthetic drugs and Biologics previously authorized for moderate and severe plaque psoriasis, which have a poor outcome in GPP. As other Biologics indicated to treat plaque psoriasis or psoriatic arthritis have distinct interleukin receptors as targets (i.e., IL-17R), spesolimab brings a new mechanism of action by binding to IL-36R (interleukin-36 receptor), thereby inhibiting IL-36 from binding to IL-36R [20], since GPP seems to have a singular mechanism in its pathogenesis involving the IL-36R [60]. Although further research is needed on this subject, current studies support the efficacy of anti-IL-36R therapy in GPP [60; 61; 62]. Briumvi(tm) (ublituximabab) (2022) is intravenously administered and it is indicated to treat relapsing forms of multiple sclerosis. Its mechanism of action is like that of Orevus(tm) (ocrelizumab), the previous mAb for multiple sclerosis approved by the FDA, in 2017. These two drugs bind to CD-20 on B-cells, both pre-B cells and mature B cells, thereby unleashing cell lysis [59; 63]. Prior to ocrelizumab, the FDA had only approved Zinbyta(tm) (daclizumab) (2016) [1], which acts by binding to a subunit of IL-2 receptors, namely CD-25. Between 2015 and 2022, only these three mAbs received the green light for this condition. Ublituximab is a chimeric mAb, and from 2015 onwards, we have seen a really low number of chimeric mAb approvals by the FDA, namely: Unituxin(tm) (dinutuximabab) in 2015; Anthim(tm) (obiltoxiximab) in 2016; Rituximab Hycela(tm) (rituximab and hyaluronidase) \begin{table}
\begin{tabular}{c c c c c c} \hline \hline
**Trade Name and** & **Class** & **Target/Mechanism of Action** & **Original** & **Manufacturer** & **Therapeutic** **Indication** \\ \hline EnjaymoTM (sutimlimb) 1 [3,56] & Humanized mAb & \begin{tabular}{c} Inhibits the complement \\ pathway and binds to complement \\ protein \\ component 1 \\ \end{tabular} & 4 February 2022 & \begin{tabular}{c} Biodiversity \\ Therapeutics, Inc. \\ \end{tabular} & \begin{tabular}{c} Decrease the need \\ of RBC transfusion \\ due to hemolysis \\ in CAD \\ \end{tabular} \\ \hline \begin{tabular}{c} SpevigoTM \\ (spesolimab) 1 [3,19; 20] \\ \end{tabular} & Humanized mAb & \begin{tabular}{c} IL36R \\ Antagonist \\ \end{tabular} & 1 September 2022 & \begin{tabular}{c} Boehringer \\ Ingelheim \\ Pharmaceuticals, \\ Inc. \\ \end{tabular} & \begin{tabular}{c} Generalized \\ Pustular Soriasis \\ Flares \\ \end{tabular} \\ \hline \begin{tabular}{c} TzieldTM \\ (teplizumab) \\ [3,57; 58] \\ \end{tabular} & Humanized mAb & Binds to CD3 & 18 November 2022 & \begin{tabular}{c} Prevention Bio, Inc \\ Type 1 Diabetes \\ \end{tabular} & \begin{tabular}{c} Delay the onset of \\ Stage 2 or 3 \\ Type 1 Diabetes \\ \end{tabular} \\ \hline \begin{tabular}{c} BriumviTM \\ (ulbituximab) [59] \\ \end{tabular} & Chimeric mAb & \
\begin{tabular}{c} Binds to CD20 \\ on B-Cells \\ \end{tabular} & 28 December 2022 &
\begin{tabular}{c} TG Therapeutics, \\ Inc. \\ \end{tabular} & Multiple Sclerosis \\ \hline \hline \end{tabular}  
* \({}^{1}\)—Orphan Drug: RBC—Red Blood Cell; CAD—Cold Agglutinin Disease; IL36R—Interleukin-36 Receptor; CD—Cluster of Differentiation.  
\end{table} 
Table 4: Biologics approved for autoimmune conditions by the Food and Drug Administration in 2022.  
in 2017; SarclisaTM (isatuximab) and MargenzaTM (margetuximab), both in 2020; and none of them are for multiple sclerosis [1], making ulbituximab the first chimeric mAb for MM.