ReviewBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2024
Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access.
Review in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled 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.
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
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.
- Comprehensive overview of antibody drug-related clinical studies in gynecology: insights from ClinicalTrials.gov.Frontiers in medicine · 2025Pooled it
- Efficacy and safety of isatuximab subcutaneous plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma: results of the Phase 2 study IZALCO.Blood cancer journal · 2025Trial
- Review
- Transitioning Therapeutic Antibodies in Oncology from Intravenous to Hyaluronidase-Facilitated Subcutaneous Administration.Clinical pharmacokinetics · 2026Review
- Evolution of bispecific and multispecific antibodies in cancer therapy.The Lancet regional health. Europe · 2026Review
- Classification system proposed to guide the design, development, regulatory approval, and scaling of long acting, small- and macro-molecule parenteral products (CS-BLAP).Journal of pharmaceutical sciences · 2026Review
- Clinical Qualification of Subcutaneous Injection Devices for Monoclonal Antibodies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Real-World Quantitative Insights into the Treatment Experience of Patients with Cancer in the USA with Subcutaneous Versus Intravenous Drug Delivery.Oncology and therapy · 2025Article
- Comparing the time spent in clinic by patients receiving, subcutaneous and intravenous formulations of cancer drugs: A pilot study.Journal of cancer policy · 2025Article
- Stick With Intravenous or Give Subcutaneous a Shot? Time and Other Considerations When Evaluating Cancer Drug Formulations.JCO oncology practice · 2025Article
- Patient Experience and Improvement Opportunities in Self-Administered, Large-Volume Subcutaneous Infusions at Home.Patient preference and adherence · 2025Article
- Subcutaneous administration of isatuximab in patients with multiple myeloma by an on-body delivery system: results of a nurse survey.Frontiers in oncology · 2025Article
- Subcutaneous delivery of immune checkpoint inhibitors: new route replacing intravenous administration?Translational lung cancer research · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In recent years, subcutaneous administration of biotherapeutics has made significant progress. The self-administration market for rheumatoid arthritis has witnessed the introduction of additional follow-on biologics, while the first subcutaneous dosing options for monoclonal antibodies have become available for multiple sclerosis. Oncology has also seen advancements with the authorization of high-volume subcutaneous formulations, facilitated by the development of high-concentration formulations and innovative delivery systems. Regulatory and Health Technology Assessment bodies increasingly consider preference data in filing dossiers, particularly in evaluating novel drug delivery methods. The adoption of a pharmacokinetic-based clinical bridging approach has become standard for transitioning from intravenous to subcutaneous administration. Non-inferiority studies with pharmacokinetics as the only primary endpoint have started deviating from traditional randomization schemes, favoring the subcutaneous route and comparing with historical intravenous data. While nonclinical and computational models made progress in predicting safety and immunogenicity for subcutaneously dosed antibodies, clinical trial evidence remains essential due to inter-individual variations and the impact of formulation parameters on anti-drug antibody formation. Ongoing technological advancements and the expanding knowledge base on pharmacokinetic-pharmacodynamic correlation across specialty areas are expected to further accelerate clinical development of subcutaneous biologics.
Indexed as
Identifiers
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.