# Tolerability and Acceptance of Switching from Brand to Generic Glatiramer Acetate in Multiple Sclerosis

**Authors:** Isabella Maraffi, Giulia Mallucci, Giulio Disanto, Rosaria Sacco, Massimiliano Tiberti, Claudio Gobbi, Chiara Zecca

PMC · DOI: 10.3390/jcm13102780 · 2024-05-09

## TL;DR

This study shows that switching from brand to generic glatiramer acetate for multiple sclerosis is safe, well-tolerated, and accepted by most patients.

## Contribution

The study provides new evidence on the safety and patient acceptance of switching from brand to generic glatiramer acetate.

## Key findings

- Patients experienced fewer local and systemic adverse events with generic GA compared to brand GA.
- Seventy-one percent of participants accepted the generic GA with a rating of 7/10 or higher.
- The median intensity of local adverse events was lower with generic GA than with brand GA.

## Abstract

Background: The costs of disease-modifying therapies (DMTs) for multiple sclerosis (MS) have increased interest in generic alternatives. Methods: This prospective and observational study aims to investigate the safety, tolerability, and acceptance of switching from brand glatiramer acetate (GA) 40 mg/mL three times per week (Copaxone®) to generic GA 40 mg/mL three times per week (Glatiramyl®). Conducted at the Neurocenter of Southern Switzerland from September 2020 to September 2021, the study enrolled 27 patients; 21 completed the study. Participants reported on local and systemic side effects three months before and after the switch, and on switch acceptance by means of visual analogue scales (from 0 to 10). Results: Results indicated that those on generic GA experienced fewer local (81.0% vs. 96.3%) and systemic (33.3% vs. 59.3%) adverse events than with the brand drug. The median intensity of local adverse events was 8 (4–20) on generic GA vs. 16 (9–22) on brand GA, while the median intensity of systemic adverse events was similar between generic and brand GA [0 (0–27) vs. 0 (0–21.5), respectively]. Seventy-one percent of participants rated their acceptance of generic GA as 7/10 or higher. Conclusions: The results suggest that switching from brand to generic GA 40 mg/mL is safe, well-tolerated, and accepted by patients with MS.

## Linked entities

- **Chemicals:** glatiramer acetate (PubChem CID 3081884)
- **Diseases:** multiple sclerosis (MONDO:0005301)

## Full-text entities

- **Diseases:** MS (MESH:D009103)
- **Chemicals:** GA (MESH:D000068717), Glatiramyl (-)
- **Species:** Homo sapiens (human, species) [taxon 9606]

## Figures

1 figure with captions in the complete paper: https://tomesphere.com/paper/PMC11122450/full.md

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Source: https://tomesphere.com/paper/PMC11122450