ReviewJournal of pharmacy practice2018
Development of Glatopa® (Glatiramer Acetate): The First FDA-Approved Generic Disease-Modifying Therapy for Relapsing Forms of Multiple Sclerosis.
Review in Journal of pharmacy practice, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 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
16 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Glatiramer Acetate Immunomodulation: Evidence of Neuroprotection and Cognitive Preservation.Cells · 2022Pooled it
- Trial
- Nanotechnology integration in oncology for advanced nanoparticle based strategies in targeted cancer diagnosis and treatment.Discover nano · 2026Review
- Advance in peptide-based drug development: delivery platforms, therapeutics and vaccines.Signal transduction and targeted therapy · 2025Review
- A narrative review on the safety of glatiramer acetate in multiple sclerosis: focus on Europe.Therapeutic advances in chronic disease · 2025Review
- Nanomedicines: Emerging Platforms in Smart Chemotherapy Treatment-A Recent Review.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Disease Modifying Strategies in Multiple Sclerosis: New Rays of Hope to Combat Disability?Current neuropharmacology · 2024Review
- A review on microfluidic-assisted nanoparticle synthesis, and their applications using multiscale simulation methods.Discover nano · 2023Review
- The good and the bad of T cell cross-reactivity: challenges and opportunities for novel therapeutics in autoimmunity and cancer.Frontiers in immunology · 2023Review
- Treatment Challenges in Multiple Sclerosis - A Continued Role for Glatiramer Acetate?Frontiers in neurology · 2022Review
- Glatiramer acetate attenuates depressive/anxiety-like behaviors and cognitive deficits induced by post-weaning social isolation in male mice.Psychopharmacology · 2021Article
- Induction of a higher-ordered architecture in glatiramer acetate improves its biological efficiency in an animal model of multiple sclerosis.Biomaterials science · 2020Article
- Therapeutic Nanoparticles and Their Targeted Delivery Applications.Molecules (Basel, Switzerland) · 2020Review
- Drug Treatment of Clinically Isolated Syndrome.CNS drugs · 2019Review
- Treatment of multiple sclerosis - success from bench to bedside.Nature reviews. Neurology · 2019Review
- Tolerability and Safety Profile of a New Brand-Generic Product of Glatiramer Acetate in Iranian Patients with Relapsing-Remitting Multiple Sclerosis: An Observational Cohort Study.Current therapeutic research, clinical and experimental · 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
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The multiple sclerosis (MS) treatment landscape in the United States has changed dramatically over the past decade. While many disease-modifying therapies (DMTs) have been approved by the US Food and Drug Administration (FDA) for the treatment of relapsing forms of MS, DMT costs continue to rise. The availability of generics and biosimilars in the MS-treatment landscape is unlikely to have a major impact on clinical benefit. However, their availability will provide alternative treatment options and potentially lower costs through competition, thus increasing the affordability of and access to these drugs. In April 2015, the first generic version of the complex drug glatiramer acetate (Glatopa® 20 mg/mL) injection was approved in the United States as a fully substitutable generic for all approved indications of the 20 mg/mL branded glatiramer acetate (Copaxone®) dosage form. Despite glatiramer acetate's complex nature-being a chemically synthesized (ie, nonbiologic) mixture of peptides-the approval occurred without conducting any clinical trials. Rather, extensive structural and functional characterization was performed to demonstrate therapeutic equivalence to the innovator drug. The approval of Glatopa signifies an important milestone in the US MS-treatment landscape, with the hope that the introduction of generic DMTs and eventually biosimilar DMTs will lead to future improvements in the affordability and access of these much-needed treatments for MS.
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.