Evidence map›Paper›PMID 40868216›Full record

ReviewBiomedicines2025

Monoclonal Antibodies (mAbs) and Proteins: The Biologic Drugs Approved by the Food and Drug Administration (FDA) in 2024.

Alexander C Martins, Mariana Y Oshiro, Beatriz N Schiavon, Glaucia A de Jesus, Beatriz G de la Torre, Fernando Albericio

Abstract readReview
In one paragraph

Review in Biomedicines, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Alexander C MartinsMedical Communication Department, IQVIA RDS, São Paulo 04719-002, Brazil.ORCID 0000-0002-7637-5410
Mariana Y OshiroEscola de Ciências da Saúde, UAM-Universidade Anhembi-Morumbi, São Paulo 03101-001, Brazil.ORCID 0000-0002-4307-5761
Beatriz N SchiavonCancer Center, A. C. Camargo (Antônio Cândido de Camargo), São Paulo 01508-010, Brazil.ORCID 0000-0002-1323-1161
Glaucia A de JesusEscola de Medicina, Universidade Nove de Julho, São Paulo 07013-110, Brazil.
Beatriz G de la TorreSchool of Laboratory Medicine and Medical Sciences, College of Health Sciences, University of KwaZulu-Natal, Durban 4001, South Africa.ORCID 0000-0001-8521-9172
Fernando AlbericioSchool of Chemistry and Physics, University of KwaZulu-Natal, Durban 4001, South Africa.ORCID 0000-0002-8946-0462

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Advances in drug development continue to play a critical role in addressing diseases, including those with unmet medical needs. In 2024, the FDA approved 50 novel drugs, 16 of which were biologics. For context, during the first half of 2024 alone, the agency approved six biologics. By mid-2025, six additional biologics have received the green light, indicating that the pace of approvals of this class of drugs this year may be on par with 2024. This paper analyzes all biologics that received FDA authorization in 2024, examining their mechanisms, clinical trials, and expedited review pathways. Key approvals included the highest number of monoclonal antibodies (mAbs) since 2015 (13 mAbs, 6 indicated for oncology), while no antibody-drug conjugates were authorized-continuing with the trend in 2023. In addition, a new chimeric mAb has been approved since the last chimeric mAb approved in 2022, and a new mAb for Alzheimer's disease. Nine biologics are first-in-class therapies, while ten received Orphan Drug Designation. The biologics considered herein fall into the categories of mAbs and proteins.

Indexed as

Alzheimer’s diseasebiologicscancerFDAfirst approvalFood and Drug Administrationmonoclonal antibody

Identifiers

PMID40868216
PMCPMC12383571

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.