ReviewBiotechnology progress
Biosimilars advancements: Moving on to the future.
Review in Biotechnology progress. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 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
25 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2016Pooled it
- Health literacy and biosimilar acceptance in people with multiple sclerosis: a cross-sectional study.BMC nursing · 2026Article
- Analytical Physicochemical and Functional Studies to Compare AryoTrust, a Follow-On Biologics, with the Originator Trastuzumab (Herceptin).Pharmaceutics · 2026Article
- Peptide Mapping for Sequence Confirmation of Therapeutic Proteins and Recombinant Vaccine Antigens by High-Resolution Mass Spectrometry: Software Limitations, Pitfalls, and Lessons Learned.International journal of molecular sciences · 2025Article
- Biosimilars: A Critical Review of Development, Regulatory Landscape, and Clinical Implications.AAPS PharmSciTech · 2025Review
- Evaluating Biosimilar Development Projects: An Analytical Framework Utilizing Net Present Value.Biologics : targets & therapy · 2025Article
- Monoclonal antibody biosimilars for cancer treatment.iScience · 2024Review
- Assessment of Functional Characterization and Comparability of Biotherapeutics: a Review.The AAPS journal · 2021Review
- On the Use of Surface Plasmon Resonance Biosensing to Understand IgG-FcγR Interactions.International journal of molecular sciences · 2021Review
- The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases.Drugs · 2020Review
- Comparative Analysis of the Biosimilar and Innovative G-CSF Modulated Pathways on Umbilical Cord Blood-Derived Mononuclear Cells.Bioinformatics and biology insights · 2020Article
- From Basic Immunology to Clinical Practice: Bio-Originators versus Bio-Similars.Mediterranean journal of rheumatology · 2019Review
- Usability of NISTmAb reference material for biosimilar analytical development.Analytical and bioanalytical chemistry · 2019Article
- Stability of Therapeutic Enzymes: Challenges and Recent Advances.Advances in experimental medicine and biology · 2019Review
- Real World Data on the Utilization Pattern and Safety Profile of Infliximab Originator Versus Biosimilars in Italy: A Multiregional Study.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2018Article
- A new CHO (Chinese hamster ovary)-derived cell line expressing anti-TNFα monoclonal antibody with biosimilar potential.Immunologic research · 2018Article
- Past, Present, and Future of Rituximab-The World's First Oncology Monoclonal Antibody Therapy.Frontiers in oncology · 2018Review
- Review
- The biosimilars journey: current status and ongoing challenges.Drugs in context · 2018Review
- Analytical characterization of recombinant hCG and comparative studies with reference product.Biologics : targets & therapy · 2018Article
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
Many patents for the first biologicals derived from recombinant technology and, more recently, monoclonal antibodies (mAbs) are expiring. Naturally, biosimilars are becoming an increasingly important area of interest for the pharmaceutical industry worldwide, not only for emergent countries that need to import biologic products. This review shows the evolution of biosimilar development regarding regulatory, manufacturing bioprocess, comparability, and marketing. The regulatory landscape is evolving globally, whereas analytical structure and functional analyses provide the foundation of a biosimilar development program. The challenges to develop and demonstrate biosimilarity should overcome the inherent differences in the bioprocess manufacturing and physicochemical and biological characterization of a biosimilar compared to several lots of the reference product. The implementation of approaches, such as Quality by Design (QbD), will provide products with defined specifications in relation to quality, purity, safety, and efficacy that were not possible when the reference product was developed. Actually, the need to prove comparability to the reference product by the biosimilar industry has increased the knowledge about the product and the production-process associated by the use of powerful analytical tools. The technological challenges to make copies of biologic products while attending regulatory and market demands are expected to help innovation in the direction of attaining more productive manufacturing processes.
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.