ArticlemAbs
Worldwide experience with biosimilar development.
Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 72 papers, 3 of them syntheses 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
72 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Safety profile of trastuzumab originator vs biosimilars: a systematic review and meta-analysis of randomized clinical trials.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Pooled it
- Pooled it
- Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab.Alimentary pharmacology & therapeutics · 2019Pooled it
- A randomized, double-blind, phase III, non-inferiority clinical trial comparing the efficacy and safety of TA4415V (a proposed Trastuzumab biosimilar) and Herceptin (Trastuzumab reference product) in HER2-positive early-stage breast Cancer patients.BMC pharmacology & toxicology · 2022Trial
- Final overall survival analysis of the phase 3 HERITAGE study demonstrates equivalence of trastuzumab-dkst to trastuzumab in HER2-positive metastatic breast cancer.Breast cancer research and treatment · 2021Trial
- A large multicentre, randomized, double-blind, cross-over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US- and EU-reference biologics.British journal of clinical pharmacology · 2020Trial
- Efficacy and safety of MYL-1501D versus insulin glargine in people with type 1 diabetes mellitus: Results of the INSTRIDE 3 phase 3 switch study.Diabetes, obesity & metabolism · 2020Trial
- Scientific Justification and Policy Recommendations to the US Food and Drug Administration for Waiving Comparative Efficacy Studies.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Contextual factors in value-based decision support to enhance health technologies adoption: the case of biosimilars.Frontiers in pharmacology · 2025Article
- Clinical Efficacy of Biosimilar Switch of Adalimumab for Management of Uveitis.Ocular immunology and inflammation · 2024Article
- Impact of Excipient Extraction and Buffer Exchange on Recombinant Monoclonal Antibody Stability.Molecular pharmaceutics · 2024Article
- Comparative physicochemical and structural characterisation studies establish high biosimilarity between BGL-ASP and reference insulin aspart.Scientific reports · 2024Article
- Article
- Reduction of biologic pricing following biosimilar introduction: Analysis across 57 countries and regions, 2012-19.PloS one · 2024Article
- Analytical and Functional Similarity of the Biosimilar Candidate ABP 654 to Ustekinumab Reference Product.Drugs in R&D · 2023Article
- Targeting Ras with protein engineering.Oncotarget · 2023Review
- Biosimilars in rare diseases: a focus on paroxysmal nocturnal hemoglobinuria.Haematologica · 2023Review
- Oncology biosimilars: New developments and future directions.Cancer reports (Hoboken, N.J.) · 2022Review
- Advancing Biologic Therapy for Refractory Autoimmune Hepatitis.Digestive diseases and sciences · 2022Review
- Structural and Functional Analysis of CEX Fractions Collected from a Novel AvastinPharmaceutics · 2022Article
12 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Limited access for high-quality biologics due to cost of treatment constitutes an unmet medical need in the United States (US) and other regions of the world. The term "biosimilar" is used to designate a follow-on biologic that meets extremely high standards for comparability or similarity to the originator biologic drug that is approved for use in the same indications. Use of biosimilar products has already decreased the cost of treatment in many regions of the world, and now a regulatory pathway for approval of these products has been established in the US. The Food and Drug Administration (FDA) led the world with the regulatory concept of comparability, and the European Medicines Agency (EMA) was the first to apply this to biosimilars. Patents on the more complex biologics, especially monoclonal antibodies, are now beginning to expire and biosimilar versions of these important medicines are in development. The new Biologics Price Competition and Innovation Act allows the FDA to approve biosimilars, but it also allows the FDA to lead on the formal designation of interchangeability of biosimilars with their reference products. The FDA's approval of biosimilars is critical to facilitating patient access to high-quality biologic medicines, and will allow society to afford the truly innovative molecules currently in the global biopharmaceutical industry's pipeline.
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.