ReviewPharmaceutical research2016
Biosimilarity Versus Manufacturing Change: Two Distinct Concepts.
Review in Pharmaceutical research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 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
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.
- Comparative effectiveness and safety of biosimilars versus reference biologics in rheumatoid arthritis during treatment initiation: a systematic review of real-world evidence.International journal of clinical pharmacy · 2025Pooled it
- Real-World Use of Off-Label MVASI in the Treatment of Patients With Neovascular AMD and DME.Translational vision science & technology · 2024Article
- Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus.Journal of clinical medicine · 2023Article
- Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009-2022.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Article
- Biosimilars in rare diseases: a focus on paroxysmal nocturnal hemoglobinuria.Haematologica · 2023Review
- Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Article
- ATR-FTIR spectroscopy and spectroscopic imaging for the analysis of biopharmaceuticals.Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy · 2020Review
- Practical Issues Concerning the Approval and Use of Biosimilar Drugs for the Treatment of Multiple Sclerosis in Latin America.Neurology and therapy · 2019Article
- From Basic Immunology to Clinical Practice: Bio-Originators versus Bio-Similars.Mediterranean journal of rheumatology · 2019Review
- Practical Guidance on Biosimilars, With a Focus on Latin America: What Do Rheumatologists Need to Know?Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases · 2019Review
- Readability assessment of package leaflets of biosimilars.BMJ open · 2019Article
- Regulation of biosimilar medicines and current perspectives on interchangeability and policy.European journal of clinical pharmacology · 2019Review
- The road from development to approval: evaluating the body of evidence to confirm biosimilarity.Rheumatology (Oxford, England) · 2017Review
- Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017Review
- Review
- A practical guide about biosimilar data for health care providers treating inflammatory diseases.Biologics : targets & therapy · 2017Review
- Differentiating biosimilarity and comparability in biotherapeutics.Clinical rheumatology · 2016Review
- Is a Biologic Produced 15 Years Ago a Biosimilar of Itself Today?American health & drug benefits · 2016Article
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 at 3 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
As products of living cells, biologics are far more complicated than small molecular-weight drugs not only with respect to size and structural complexity but also their sensitivity to manufacturing processes and post-translational changes. Most of the information on the manufacturing process of biotherapeutics is proprietary and hence not fully accessible to the public. This information gap represents a key challenge for biosimilar developers and plays a key role in explaining the differences in regulatory pathways required to demonstrate biosimilarity versus those required to ensure that a change in manufacturing process did not have implications on safety and efficacy. Manufacturing process changes are frequently needed for a variety of reasons including response to regulatory requirements, up scaling production, change in facility, change in raw materials, improving control of quality (consistency) or optimising production efficiency. The scope of the change is usually a key indicator of the scale of analysis required to evaluate the quality. In most cases, where the scope of the process change is limited, only quality and analytical studies should be sufficient while comparative clinical studies can be required in case of major changes (e.g., cell line changes). Biosimilarity exercises have been addressed differently by regulators on the understanding that biosimilar developers start with fundamental differences being a new cell line and also a knowledge gap of the innovator's processes, including culture media, purification processes, and potentially different formulations, and are thus required to ensure that differences from innovators do not result in differences in efficacy and safety.
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.