# FDA Approvals of Biologics in 2022
## 5 Discussion  
The quantitative aspect of total drug approvals by the FDA in 2022 could lead to some concern as it ranks as the second year with the lowest number [30]. However, as seen in 2016, factors such as fewer submissions and/or an increase in rejections by the FDA [11; 12] may have occurred. Possible political influences should also be considered, including the end of the pandemic in many countries, as well as the slow process which is demanded to obtain the final approval or delays in the processes, as seen in 2016 [12], for example. In the same way, this year, a few drugs could have had an expected approval deadline in 2022, but, due to delays, perhaps they are going to be approved in 2023. This decrease in authorizations should not be interpreted as a greater failure on the part of the pharmaceutical industry, as authorization has been granted to key drugs and there has been a trend to devote resources to an increasing number of rare diseases and conditions. It should be noted that the decrease in the approvals in 2022 only applied to the small molecules category, not to Biologics. In this regard, 15 Biologics have been approved in 2022. In terms of the period 2015-2022, this year is among those with the highest number of biopharmaceuticals to receive the green light [1; 30]. Special mention is given to four Biologics: the first bispecific fusion protein approved to date, namely KimmtrakTM (tebentafusp), and the antibodies VabysmoTM (faricimab), TecvayliTM (tcelistamab), and LumsumioTM (mosuentuzumab), two of which are Orphan Drugs. This harvest makes 2022 the year with the highest number of bispecific biologic products to receive authorization. Of note, VabysmoTM is produced by the giant Genentech, which also manufactures two of the Biologics approved in 2022. This company has received authorization for a Biologic almost every year between 2015 and 2022. Indeed, in 2017, three of its Biologics received the green light. Although cancer continues to be the most targeted disease for Biologics, only six out of the fifteen drugs authorized in 2022 are indicated for cancer. This may indicate a trend towards targeting other diseases. The harvest of 2022 included an ADC, ElahereTM, which, like all the other ADCs approved to date, is indicated for cancer. However, it carries a distinct payload from previous ADCs. As in previous years, in 2022, autoimmuneconditions continued to be the second in the ranking of targets after cancer, with four out of the fifteen Biologics authorized for this indication. For aesthetic purposes, 2022 saw the approval of DaxifyTM (daxibotulinumtoxin A), the effects of which proved to have a longer duration than those of the widely used onabotulinumtoxin A. Of note, the last botulinum toxin to be approved, prabotulinumtoxin A, was in 2019. It could be speculated that there is an emerging trend to provide alternatives to BotoxTM. DaxifyTM falls into the natural product section, along with NexoBridTM (anacaulase), a mixture of enzymes from pineapple [30; 79; 80; 94]. Regarding the efficacy of the other Biologics in 2022, so far, data show that they were all either superior to previous Biologics or non-inferior. Each year brings approvals for new targets and 2022 was no different. In this regard, important advancements were made, such as KimmtrakTM (tebentafusp). In addition to being the first bispecific fusion protein, it is the first Biologic indicated for the treatment of unresectable or metastatic uveal melanoma. Furthermore, SpevigoTM (spesolimab) is the first mAb to specifically treat generalized pustular psoriasis flares [19; 20]. Both drugs have been granted Orphan Drug Status by the FDA. In the context of the increasing concern regarding antibiotic resistance worldwide, the pharmaceutical industry appears to be struggling to develop antibacterial Biologics. This is reflected by the fact that only two such products have been authorized since 2015 [1]. The complexity of bacteria and the presence of polymicrobial infections may hinder the development of such Biologics.