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

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.

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.

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