FDA Approvals of Biologics in 2022
The year 2022 witnessed the control of the COVID-19 pandemic in most countries through social and hygiene measures and also vaccination campaigns. It also saw a decrease in total approvals by the U.S. Food and Drug Administration (FDA). Nevertheless, there was no fall in the Biologics class, which w...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-05-01
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| Series: | Biomedicines |
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| Online Access: | https://www.mdpi.com/2227-9059/11/5/1434 |
| _version_ | 1827741910186328064 |
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| author | Alexander C. Martins Fernando Albericio Beatriz G. de la Torre |
| author_facet | Alexander C. Martins Fernando Albericio Beatriz G. de la Torre |
| author_sort | Alexander C. Martins |
| collection | DOAJ |
| description | The year 2022 witnessed the control of the COVID-19 pandemic in most countries through social and hygiene measures and also vaccination campaigns. It also saw a decrease in total approvals by the U.S. Food and Drug Administration (FDA). Nevertheless, there was no fall in the Biologics class, which was boosted through the authorization of 15 novel molecules, thus maintaining the figures achieved in previous years. Indeed, the decrease in approvals was only for the category of small molecules. Monoclonal antibodies (mAbs) continued to be the drug class with the most approvals, and cancer remained the most targeted disease, followed by autoimmune conditions, as in previous years. Interestingly, the FDA gave the green light to a remarkable number of bispecific Biologics (four), the highest number in recent years. Indeed, 2022 was another year without the approval of an antimicrobial Biologic, although important advancements were made in targeting new diseases, which are discussed herein. In this work, we only analyze the Biologics authorized in 2022. Furthermore, we also consider the orphan drugs authorized. We not only apply a quantitative analysis to this year’s harvest, but also compare the efficacy of the Biologics with those authorized in previous years. On the basis of their chemical structure, the Biologics addressed fall into the following classes: monoclonal antibodies; antibody-drug conjugates; and proteins/enzymes. |
| first_indexed | 2024-03-11T03:54:47Z |
| format | Article |
| id | doaj.art-773ce610f9ce44eba77afa2949371a99 |
| institution | Directory Open Access Journal |
| issn | 2227-9059 |
| language | English |
| last_indexed | 2024-03-11T03:54:47Z |
| publishDate | 2023-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Biomedicines |
| spelling | doaj.art-773ce610f9ce44eba77afa2949371a992023-11-18T00:37:02ZengMDPI AGBiomedicines2227-90592023-05-01115143410.3390/biomedicines11051434FDA Approvals of Biologics in 2022Alexander C. Martins0Fernando Albericio1Beatriz G. de la Torre2School of Health Sciences, UAM, Universidade Anhembi-Morumbi, São Paulo 03101-001, BrazilSchool of Chemistry and Physics, University of KwaZulu-Natal, Durban 4001, South AfricaKRISP, College of Health Sciences, University of KwaZulu-Natal, Durban 4001, South AfricaThe year 2022 witnessed the control of the COVID-19 pandemic in most countries through social and hygiene measures and also vaccination campaigns. It also saw a decrease in total approvals by the U.S. Food and Drug Administration (FDA). Nevertheless, there was no fall in the Biologics class, which was boosted through the authorization of 15 novel molecules, thus maintaining the figures achieved in previous years. Indeed, the decrease in approvals was only for the category of small molecules. Monoclonal antibodies (mAbs) continued to be the drug class with the most approvals, and cancer remained the most targeted disease, followed by autoimmune conditions, as in previous years. Interestingly, the FDA gave the green light to a remarkable number of bispecific Biologics (four), the highest number in recent years. Indeed, 2022 was another year without the approval of an antimicrobial Biologic, although important advancements were made in targeting new diseases, which are discussed herein. In this work, we only analyze the Biologics authorized in 2022. Furthermore, we also consider the orphan drugs authorized. We not only apply a quantitative analysis to this year’s harvest, but also compare the efficacy of the Biologics with those authorized in previous years. On the basis of their chemical structure, the Biologics addressed fall into the following classes: monoclonal antibodies; antibody-drug conjugates; and proteins/enzymes.https://www.mdpi.com/2227-9059/11/5/1434monoclonal antibodiesantibody-drug conjugatefirst approvalFDABiologicsanacaulase |
| spellingShingle | Alexander C. Martins Fernando Albericio Beatriz G. de la Torre FDA Approvals of Biologics in 2022 Biomedicines monoclonal antibodies antibody-drug conjugate first approval FDA Biologics anacaulase |
| title | FDA Approvals of Biologics in 2022 |
| title_full | FDA Approvals of Biologics in 2022 |
| title_fullStr | FDA Approvals of Biologics in 2022 |
| title_full_unstemmed | FDA Approvals of Biologics in 2022 |
| title_short | FDA Approvals of Biologics in 2022 |
| title_sort | fda approvals of biologics in 2022 |
| topic | monoclonal antibodies antibody-drug conjugate first approval FDA Biologics anacaulase |
| url | https://www.mdpi.com/2227-9059/11/5/1434 |
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