ArticlemAbs2014
Biosimilars entering the clinic without animal studies. A paradigm shift in the European Union.
Article in mAbs, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
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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.
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Who cites it
16 citing papers in PubMed.
- Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Review
- Evolution of the EU Biosimilar Framework: Past and Future.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2019Review
- An Efficient Development Paradigm for Biosimilars.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2019Article
- Regulation of biosimilar medicines and current perspectives on interchangeability and policy.European journal of clinical pharmacology · 2019Review
- Biosimilar Drugs for Psoriasis: Principles, Present, and Near Future.Dermatology and therapy · 2018Review
- The use of biosimilar medicines in oncology - position statement of the Brazilian Society of Clinical Oncology (SBOC).Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2018Article
- The road from development to approval: evaluating the body of evidence to confirm biosimilarity.Rheumatology (Oxford, England) · 2017Review
- Review
- Opportunities to Apply the 3Rs in Safety Assessment Programs.ILAR journal · 2016Article
- Nonclinical Evaluation of PF-06438179: A Potential Biosimilar to RemicadeAdvances in therapy · 2016Article
- The changing landscape of biosimilars in rheumatology.Annals of the rheumatic diseases · 2016Review
- Review
- Augmented Binary Substitution: Single-pass CDR germ-lining and stabilization of therapeutic antibodies.Proceedings of the National Academy of Sciences of the United States of America · 2015Article
- [Regulatory aspects of biosimilars. Myths and facts].Zeitschrift fur Rheumatologie · 2015Article
- Review
- Biosimilars advancements: Moving on to the future.Biotechnology progressReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The concept of biosimilars has spread from Europe to other regions throughout the world, and many regions have drafted regulatory guidelines for their development. Recently, a paradigm shift in regulatory thinking on the non-clinical development of biosimilars has emerged in Europe: In vivo testing should follow a step-wise approach rather than being performed by default. To not require animal testing at all in some instances can well be seen as a revolutionary, but science-based, step. Here, we describe the internal discussions that led to this paradigm shift. The mainstay for the establishment of biosimilarity is the pharmaceutical comparability based on extensive physicochemical and biological characterization. Pharmacodynamic comparability can be evaluated in in vitro assays, whereas pharmacokinetic comparability is best evaluated in clinical studies. It is considered highly unlikely that new safety issues would arise when comparability has been demonstrated based on physicochemical and in vitro comparative studies.
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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.