ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2026
Expanding Patient Access to Advanced Therapies.
Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
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.
Funding
Abstract
Advanced therapy medicinal products (ATMPs) promise transformative clinical potential, but their use remains limited by complex manufacturing, high prices, and fragmented market access. To explore the existing and potential regulatory pathways to increase access to ATMPs, we conducted a product-level analysis of ATMPs and biologic medicines submitted to the European Medicines Agency up to May 2026, and a review of regulatory pathways and policy frameworks. While certain scientific principles from biologic and biosimilar regulation, such as totality of evidence, fit-for-purpose data, and tailored approaches are transferable, the biosimilar pathway may not be suitable for certain ATMPs. Other approaches, including bio-hybrid applications or prior knowledge-based dossiers, may be better suited to support competitive entry and second-wave innovation. Tailored follow-on pathways, open and well governed platform technologies, and supportive industrial and data sharing policies, are key to facilitate the translation of the scientific promise of ATMPs into sustainable and equitable patient access.
Identifiers
42481849What Socratic 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 Socratic graph.