Food and Drug Administration (FDA) Approvals of Biological Drugs in 2023-Reference-Cited by-同舟云学术

Food and Drug Administration (FDA) Approvals of Biological Drugs in 2023

Published:2024-09-02 Issue:9 Volume:12 Page:1992
ISSN:2227-9059
Container-title:Biomedicines
language:en
Short-container-title:Biomedicines

Author:

Martins Alexander C.¹²^ORCID,Oshiro Mariana Y.¹^ORCID,Albericio Fernando³⁴^ORCID,de la Torre Beatriz G.⁵^ORCID

Affiliation:

1. School of Health Sciences, UAM, Universidade Anhembi-Morumbi, São Paulo 03101-001, Brazil

2. Medical Information Department, Thermo Fisher Scientific, São Paulo 4542011, Brazil

3. School of Chemistry and Physics, University of KwaZulu-Natal, Durban 4001, South Africa

4. CIBER-BBN, Networking Centre on Bioengineering, Biomaterials and Nanomedicine, Department of Organic Chemistry, University of Barcelona, 08028 Barcelona, Spain

5. KRISP, College of Health Sciences, University of KwaZulu-Natal, Durban 4001, South Africa

Abstract

An increase in total drug (small molecules and biologics) approvals by the Food and Drug Administration (FDA) was seen in 2023 compared with the previous year. Cancer remained the disease most targeted by monoclonal antibodies (mAbs), followed by autoimmune conditions. Our data reveal the prevalence of approvals for biologics even during years when the total number of authorizations was low, such as in 2022. Over half the drugs that received the green light in 2023 benefited from expedited programs, as the incidence of many diseases increased. In addition, over half of the biologics approved received Orphan Drug Designation from the FDA. This narrative review delves into details of the most significant approvals in 2023, including mAbs, enzymes, and proteins, explaining their mechanisms of action, differences from previous drugs, placebo, and standards of care, and outcomes in clinical trials. Given the varying number of drugs authorized annually by the U.S. health authority, this review also examines the limits of external influences over the FDA′s decisions and independence regarding drug approvals and withdrawals.

Funder

University of KwaZulu-Natal

Publisher

MDPI AG

Link

https://www.mdpi.com/2227-9059/12/9/1992/pdf

Reference177 articles.

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