ReviewBiomedicines2022
Trends and Perspectives of Biological Drug Approvals by the FDA: A Review from 2015 to 2021.
Review in Biomedicines, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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.
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.
Who cites it
15 citing papers in PubMed, 32 citations in OpenAlex.
- Advancing PEGylated Drug Evaluation: A Novel Approach to Pegfilgrastim Pharmacokinetic Assessment.Clinical and translational science · 2026Article
- Biologics and Drug-Induced Immunogenicity: A Case Report of Acquired Hemophilia A Presenting After Immunotherapy.Clinical case reports · 2026Article
- Outstanding Contributions to Aerosol Pulmonary Drug Delivery.Kona : powder science and technology in Japan · 2026Article
- Article
- Microsampling in toxicology studies - maximising the scientific, business and 3Rs advantages.Toxicology research · 2025Article
- Feature Reviews in Medicinal Chemistry.Pharmaceuticals (Basel, Switzerland) · 2025Article
- New drug comments: aiming to deliver useful, timely, independent information for health professionals.Australian prescriber · 2025Article
- Technological and industrial trends in China's pharmaceutical sector.Frontiers in pharmacology · 2025Review
- Food and Drug Administration (FDA) Approvals of Biological Drugs in 2023.Biomedicines · 2024Review
- Predicting the Stability of Lyophilized Human Serum Albumin Formulations Containing Sucrose and Trehalose Using Solid-State NMR Spectroscopy: Effect of Storage Temperature onThe AAPS journal · 2024Article
- Sample transformation in online separations: how chemical conversion advances analytical technology.Chemical communications (Cambridge, England) · 2023Review
- Highly protein-loaded melt extrudates produced by small-scale ram and twin-screw extrusion - evaluation of extrusion process design on protein stability by experimental and numerical approaches.International journal of pharmaceutics: X · 2023Article
- FDA Approvals of Biologics in 2022.Biomedicines · 2023Review
- bioTCIs: Middle-to-Macro Biomolecular Targeted Covalent Inhibitors Possessing Both Semi-Permanent Drug Action and Stringent Target Specificity as Potential Antibody Replacements.International journal of molecular sciences · 2023Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Despite belonging to a relatively new class of pharmaceuticals, biological drugs have been used since the 1980s, when they brought about a breakthrough in the treatment of chronic diseases, especially cancer. They conquered a large space in the pipeline of the pharmaceutical industry and boosted the innovation portfolio and arsenal of therapeutic compounds available. Here, we report on biological drug approvals by the US Food and Drug Administration (FDA) from 2015 to 2021. The number of drugs included in this class grew over this period, totaling 90 approvals, with an average of 13 authorizations per year. This figure contrasts with previous periods, which registered between 2 and 8 approvals per year. We highlight the great potential and advantages of biological drugs. In this context, these therapeutics show high efficacy and high selectivity, and they have brought about a significant increase in patient survival and a reduction of adverse reactions. The development and production of biopharmaceuticals pose a major challenge because these processes require cutting-edge technology, thereby making the drugs very expensive. However, we believe that, in the near future, biological medicines will be more accessible and new drugs belonging to this class will become available as new technologies emerge. Such advances will enhance the production of these biopharmaceuticals, thereby making the process increasingly profitable and less expensive, thereby bringing about greater availability of these drugs.
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What OpenQuestion holds
Registered trials
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.