Food and Drug Administration (FDA) Approvals of Biological Drugs in 2023
Abstract
:1. Introduction
2. Analysis of Biological Drug Approvals and External Influences over the FDA
3. Timeline for FDA-Approved Biologics
4. Alzheimer’s Disease—Lecanemab
5. Enzymes and Proteins
6. Non-Central Nervous System Manifestations of α-Mannosidosis—Velmanase-α
7. Fabry Disease—Pegunigalsidase-α
8. Pompe Disease—Cipaglucosidase-α
9. Pituitary Hormone Deficiency—Somatrogon
10. Cancer
10.1. Rising Cancer Cases
10.2. Biologics Approved for Cancer Treatment in 2023
11. Merkel Cell Carcinoma (MCC)—Retifanlimab
12. Diffuse Large B-Cell Lymphoma (DLBCL)—Epcoritamab
13. Multiple Myeloma (MM)—Elranatamab
14. Nasopharyngeal Carcinoma (NPC)—Toripalimab
15. Autoimmune Conditions
16. Generalized Myasthenia Gravis (gMG)—Rozanolixizumab
17. Plaque Psoriasis—Bimekizumab
18. Ulcerative Colitis (UC)—Mirikizumab
19. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Year |
Total Drugs Approved (Biologics and NCEs) | Biologics Approved | References |
---|---|---|---|
2023 | 55 | 17 (30.9%) | [12] |
2022 | 37 | 15 (40.5%) | [13] |
2021 | 50 | 14 (28%) | [14] |
2020 | 53 | 15 (28.3%) | [15] |
2019 | 48 | 12 (25%) | [16] |
2018 | 59 | 17 (28.8%) | [17] |
2017 | 46 | 13 (28.2%) | [18] |
2016 | 22 | 7 (31.8%) | [19] |
2015 | 45 | 13 (28.8%) | [20] |
2015–2023 | 415 | 123 (29.6%) |
Year | Biologics Approved | Orphan Drug Designations Granted for New Biologics |
---|---|---|
2015 | 13 | 7 (53%) |
2016 | 7 | 2 (28%) |
2017 | 13 | 5 (38%) |
2018 | 17 | 13 (76%) |
2019 | 12 | 9 (75%) |
2020 | 15 | 10 (66%) |
2021 | 14 | 7 (50%) |
2022 | 15 | 7 (53%) |
2023 | 17 | 9 (52.9%) |
2015–2023 | 123 | 60 (48.78%) |
Drug Name | Class and Administration | Mechanism of Action | Original Approval Date | Pharmaceutical Company | Therapeutic Indication |
---|---|---|---|---|---|
LeqembiTM (lecanemab-irmb) [12,40,41] | Humanized mAb (IgG1) (intravenously) | Acts against aggregated soluble and insoluble forms of amyloid-β peptide | 6 January 2023 | Eisai, Inc., Nutley, NJ, USA, and Biogen, Cambridge, MA USA | Alzheimer′s disease |
Drug Name | Class and Administration | Mechanism of Action | Original Approval Date | Pharmaceutical Company | Therapeutic Indication |
---|---|---|---|---|---|
LamzedeTM (velmanase α -tycv) * [12,32,66,67] | Recombinant human enzyme (intravenously) | Catalyzes the degradation of accumulated mannose-containing oligosaccharides | 16 February 2023 | Chiesi Farmaceutici S.p.A, Parma, Italy | Non-central nervous system manifestations of α -mannosidosis |
ElfabrioTM (pegunigalsidase α -iwxj) [12,68] | Hydrolytic lysosomal neutral glycosphingolipid-specific enzyme (intravenously) | Provides an exogenous source of α-galactosidase | 9 May 2023 | Chiesi Farmaceutici S.p.A., Parma Italy | Fabry disease |
NgenlaTM (somatrogon-ghla) * [12,29,69] | Human growth hormone analog (rhGH) (fusion protein) (subcutaneously) | Binds to the GH receptor, leading to an increase in serum concentration of IGF-1 | 27 June 2023 | Pfizer Ireland Pharmaceuticals, Ringaskiddy, Ireland | Pediatric patients who have growth failure |
PombilitiTM (cipaglucosidase α -atga) * [12,25,70] | Recombinant human acid α -glucosidase (exogenous source of GAA) (intravenously) | Binds to the CI-MPR in skeletal muscle | 28 September 2023 | Amicus Therapeutics, Philadelphia, PA USA | Late-onset Pompe disease |
RyzneutaTM (efbemalenograstim α -vuxw) [12,71] | G-CSF (recombinant fusion protein) (subcutaneously) | Stimulates the differentiation of stem cells, increasing neutrophils | 16 November 2023 | Evive Biotechnology Singapore PTE. LTD., Singapore | Neutropenia in adult patients receiving anti-cancer drugs |
Biological Drug. | Dosage Forms | Most Common Adverse Reactions (≥5%) | Administration |
---|---|---|---|
Somatrogon | Prefilled pen | Pyrexia, injection site reactions, nasopharyngitis, headache, anemia, cough, vomiting, hypothyroidism, abdominal pain, rash, and oropharyngeal pain | Subcutaneous injection (once weekly) |
Somapacitan | Pyrexia, nasopharyngitis, headache, pain in extremities, and injection site reaction | ||
Lonapegsomatropin | Prefilled cartridges (lyophilized powder, dual-chamber, prefilled cartridges, and diluent) | Pyrexia, viral infection, cough, nausea and vomiting, hemorrhage, diarrhea, abdominal pain, and arthralgia and arthritis |
Drug Name | Class and Administration | Mechanism of Action | Original Approval Date | Pharmaceutical Company | Therapeutic Indication |
---|---|---|---|---|---|
BeyfortusTM (nirsevimab-alip) [92,93,94] | Recombinant human mAb (IgG1k) (intramuscular use) | Neutralizes RSV by inhibiting conformation changes in the F protein necessary for the fusion of the viral and cellular membranes and viral entry | 17 July 2023 | AstraZeneca AB, England, UK, and Sanofi, Paris, France | Prevention of RSV |
Drug Name | Class and Administration | Mechanism of Action | Original Approval Date | Pharmaceutical Company | Therapeutic Indication |
---|---|---|---|---|---|
ZynyzTM (retifanlimab-dlwr) * [12,31,97,98] | Humanized mAb (IgG4) (intravenously) | Binds to the PD-1 receptor found on T-cells, blocking interaction with PD-L1 and PD-L2 | 22 March 2023 | Incyte Corporation, Wilmington, DE USA | M/R locally advanced Merkel cell carcinoma |
EpkinlyTM (epcoritamab-bysp) [12,99,100] | Humanized bispecific mAb (IgG1) (subcutaneously) | Simultaneously binds to CD3 on T-cells and CD20 on B-cells | 19 May 2023 | Co-developed by Genmab USA, Inc., Plainsboro, NJ, USA and AbbVie, North Chicago, IL, USA | R/R DLBCL (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma |
ColumviTM (glofitamab-gxbm) [12,101,102] | Humanized bispecific mAb (IgG1) (intravenously) | Simultaneously binds to CD3 on T-cells and CD20 on B-cells | 15 June 2023 | Genentech, Inc., South San Francisco, CA, USA | R/R DLBCL (NOS) or LBCL arising from follicular lymphoma |
TalveyTM (talquetamab-tgvs) * [28,103,104] | Humanized bispecific mAb (IgG4-PAA) (subcutaneously) | Acts as anti-GPRC5D heavy and light chain and anti-CD3 heavy and light chain | 9 August 2023 | Janssen Biotech, Inc., Beerse, Belgium | R/R multiple myeloma patients who have received at least four prior line therapies |
ElrexfioTM (elranatamab-bcmm) * [27,105,106,107] | Humanized bispecific mAb (IgG2Δa) (subcutaneously) | Binds BCMA on plasma cells, plasmablasts, and multiple myeloma cells and CD3 on T-cells | 14 August 2023 | Pfizer Inc., New York, NY, USA | R/R multiple myeloma patients who have received at least four prior lines of therapy |
LoqtorziTM (toripalimab-tpzi) * [24,108,109] | Humanized mAb (IgG4K) (intravenously) | Binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2 | 27 October 2023 | Coherus BioSciences, Inc., Redwood City, CA, USA | Adults with M/R NPC and as a single agent for the treatment of adults with M/Ru NPC |
Drug Name | Class and Administration | Mechanism of Action | Original Approval Date | Pharmaceutical Company | Therapeutic Indication |
---|---|---|---|---|---|
RystiggoTM (rozanolixizumab-noli) * [12,30,143] | Humanized IgG4P mAb (subcutaneously) | Blocks FcRn, reducing the amount of free IgG | 26 June 2023 | UCB, Inc., Brussels, Belgium (Union Chimique Belge) | gMG in adult patients who are AChR or anti-MuSK antibody-positive |
BimzelxTM (bimekizumab-bkzx) [12,144] | Humanized mAb (IgG1) (subcutaneously) | Binds to human IL-17A, IL17F, and IL-17-AF cytokines | 17 October 2023 | UCB, Inc., Brussels, Belgium (Union Chimique Belge) | Moderate to severe plaque psoriasis in adults |
OmvohTM (mirikizumab-mrkz) [12,145] | Humanized mAb (IgG4) (intravenously) | Binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor | 26 October 2023 | Eli Lilly and Company, New York, NY, USA | Moderate to severe active ulcerative colitis in adults |
VeopozTM (pozelimab-bbfg) * [146,147] | Human mAb (IgG 4) (intravenously) | Blocks the activity of C5 and prevents diseases mediated by the complement pathway | 18 August 2023 | Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA | CD55-deficient PLE, also known as Chaple disease in patients aged 1 year and older |
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Martins, A.C.; Oshiro, M.Y.; Albericio, F.; de la Torre, B.G. Food and Drug Administration (FDA) Approvals of Biological Drugs in 2023. Biomedicines 2024, 12, 1992. https://doi.org/10.3390/biomedicines12091992
Martins AC, Oshiro MY, Albericio F, de la Torre BG. Food and Drug Administration (FDA) Approvals of Biological Drugs in 2023. Biomedicines. 2024; 12(9):1992. https://doi.org/10.3390/biomedicines12091992
Chicago/Turabian StyleMartins, Alexander C., Mariana Y. Oshiro, Fernando Albericio, and Beatriz G. de la Torre. 2024. "Food and Drug Administration (FDA) Approvals of Biological Drugs in 2023" Biomedicines 12, no. 9: 1992. https://doi.org/10.3390/biomedicines12091992