ReviewDrug design, development and therapy2017
Ten years of biosimilars in Europe: development and evolution of the regulatory pathways.
Review in Drug design, development and therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 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
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Is There Any Research Evidence Beyond Surveys and Opinion Polls on Automatic Substitution of Biological Medicines? A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Pooled it
- A prospective, randomized, parallel group, double blind, multicenter study to compare the efficacy, safety and immunogenicity of Lupin's Ranibizumab with LucentisIndian journal of ophthalmology · 2022Trial
- Trial
- Regulatory Definitions and Classification of Biosimilar Medications Across the 6 Regions of the World Health Organization: A Scoping Review.JAMA health forum · 2026Article
- Horizon scan of the clinical development landscape of biosimilar products in the UK and EU.International journal of technology assessment in health care · 2026Article
- Drug Delivery Technologies for the Treatment of Age-Related Macular Degeneration.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Review
- Evaluating biosimilars: safety, efficacy, and regulatory considerations in clinical studies.International journal of clinical pharmacy · 2025Review
- Cancer treatment with biosimilar drugs: A review.Cancer innovation · 2024Review
- Under the Umbrella of Clinical Pharmacology: Inflammatory Bowel Disease, Infliximab and Adalimumab, and a Bridge to an Era of Biosimilars.Pharmaceutics · 2022Review
- Analysis of the Regulatory Science Applied to a Single Portfolio of Eight Biosimilar Product Approvals by Four Key Regulatory Authorities.Pharmaceuticals (Basel, Switzerland) · 2021Article
- Association Between Filgrastim Biosimilar Availability and Changes in Claim Payments and Patient Out-of-Pocket Costs for Biologic Filgrastim Products.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2020Article
- ATR-FTIR spectroscopy and spectroscopic imaging for the analysis of biopharmaceuticals.Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy · 2020Review
- Evaluation of Structural, Biological, and Functional Similarity of Biosimilar Granulocyte Colony Stimulating Factor to its Reference Product.Pharmaceutical research · 2020Article
- The Path Towards a Tailored Clinical Biosimilar Development.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Review
- Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey.Pharmacoepidemiology and drug safety · 2019Review
- Aptamers as quality control tool for production, storage and biosimilarity of the anti-CD20 biopharmaceutical rituximab.Scientific reports · 2019Article
- Patients' and nurses' preferences for autoinjectors for rheumatoid arthritis: results of a European survey.Patient preference and adherence · 2018Article
- Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines.Frontiers in pharmacology · 2018Review
- Biosimilars: Key regulatory considerations and similarity assessment tools.Biotechnology and bioengineering · 2017Review
- Ten years of biosimilar recombinant human growth hormone in Europe.Drug design, development and therapy · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A biosimilar is defined by the European Medicines Agency as a biological medicine that is similar to another biological medicine that has already been authorized for use. A science-based regulatory framework to ensure high-quality biosimilars has been established in Europe since 2005 and is monitored and updated on an ongoing basis. The guiding principle of a biosimilar development program is to establish similarity between the biosimilar and the reference medicine by the best possible means, ensuring that the previously proven safety and efficacy of the reference medicinal product also applies to the biosimilar. Development of a biosimilar is underpinned by state-of-the-art analytical techniques to characterize both reference medicines and biosimilars. The extent and nature of the nonclinical in vivo studies and clinical studies to be performed depend on the level of evidence obtained in the previous step(s), including the robustness of the physicochemical, biological, and nonclinical in vitro data. Extrapolation is an important element of the biosimilarity concept. When biosimilar comparability has been demonstrated in one indication, extrapolation of the data package to other indications of the reference medicine could be acceptable, but needs to be scientifically justified and considered in light of the demonstrated level of sameness by all analytical, nonclinical, and clinical data. The credibility of the scientific basis behind the biosimilar concept, and quality of regulatory decision-making, is demonstrated by the successful approval and clinical use of 20 biosimilar medicines since 2006 when Omnitrope
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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.