ReviewJournal of industrial microbiology & biotechnology2019
Current perspectives on biosimilars.
Review in Journal of industrial microbiology & biotechnology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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
17 citing papers in PubMed.
- Biosimilars in diabetic macular edema: Promise, progress, and pitfalls.Indian journal of ophthalmology · 2026Review
- Critical analysis of withdrawn drug applications in marketing authorization procedures of the European Medicines Agency (EMA) 2006-2024.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Regulatory and safety challenges of biosimilars: insights from developed and emerging economies.European journal of clinical pharmacology · 2026Review
- Navigating Regulatory Complexities in Biosimilar Approvals and Imports for Autoimmune Disorder Management: A Comparative Analysis of FDA (US), EMA (EU), and CDSCO (India) Guidelines.Recent advances in drug delivery and formulation · 2026Article
- Current status and trends of anti-tumor biosimilars in China from 2019 to 2023: A cross-sectional analysis.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2025Article
- Biosimilars: A Critical Review of Development, Regulatory Landscape, and Clinical Implications.AAPS PharmSciTech · 2025Review
- Biosimilars in the Era of Artificial Intelligence-International Regulations and the Use in Oncological Treatments.Pharmaceuticals (Basel, Switzerland) · 2024Review
- An Overview of Biosimilars-Development, Quality, Regulatory Issues, and Management in Healthcare.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Understanding Biosimilar Insulins - Development, Manufacturing, and Clinical Trials.Journal of diabetes science and technology · 2023Review
- Biosimilars in rare diseases: a focus on paroxysmal nocturnal hemoglobinuria.Haematologica · 2023Review
- Under the Umbrella of Clinical Pharmacology: Inflammatory Bowel Disease, Infliximab and Adalimumab, and a Bridge to an Era of Biosimilars.Pharmaceutics · 2022Review
- Commercial Low Molecular Weight Heparins - Patent Ecosystem and Technology Paradigm for Quality Characterization.Journal of pharmaceutical innovation · 2022Article
- Report from the CVOT Summit 2021: new cardiovascular, renal, and glycemic outcomes.Cardiovascular diabetology · 2022Article
- From Biologics to Biosimilars and Biobetters - Democratization of High-end Therapeutics.Indian journal of ophthalmology · 2021Article
- The promising drugs included in WHO's Solidarity Project: a choice based in scientific knowledge and institutional competencies.Memorias do Instituto Oswaldo Cruz · 2021Article
- Challenging Bioanalyses with Capillary Electrophoresis.Analytical chemistry · 2020Review
- Recent Developments in Bioprocessing of Recombinant Proteins: Expression Hosts and Process Development.Frontiers in bioengineering and biotechnology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In this work, an overview of the biosimilars market, pipeline and industry targets is discussed. Biosimilars typically have a shorter timeline for approval (8 years) compared to 12 years for innovator drugs and the development cost can be 10-20% of the innovator drug. The biosimilar pipeline is reviewed as well as the quality management system (QMS) that is needed to generate traceable, trackable data sets. One difference between developing a biosimilar compared to an originator is that a broader analytical foundation is required for biosimilars and advances made in developing analytical similarity to characterize these products are discussed. An example is presented on the decisions and considerations explored in the development of a biosimilar and includes identification of the best process parameters and methods based on cost, time, and titer. Finally factors to consider in the manufacture of a biosimilar and approaches used to achieve the target-directed development of a biosimilar are discussed.
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.