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DIR Return to: COPAXONE, GLATOPA (glatiramer acetate)
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#Post#: 507--------------------------------------------------
Generic Copaxone probably as good as the brand-name
DIR By: agate
Date: October 7, 2014, 6:52 pm
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From the MS Research Roundup, MS Discovery Forum, October 3,
2014:
--- Quote ---
> Copaxone Meets Its Match in Generic
>
> In the United States, MS drugs cost patients—or their health
insurance plans—an estimated $40,000 to $50,000 per year. That
makes a potential generic drug huge news. A phase 3 head-to-head
trial of a generic version of glatiramer acetate versus the
original Copaxone (Teva) suggested that the generic version
works as well as the brand name for new lesions (as measured by
T1 gadolinium-enhancing MRI) and reducing relapses, with similar
rates of adverse events. If approved by the U.S. Food and Drug
Administration, this could be the first U.S.-approved generic
drug for MS. The researchers tested the generic against both
Copaxone and a placebo in 735 patients with RRMS for 9 months.
Of course, researchers are still nailing down exactly how the
original drug works.
>
> In an article published earlier this week in JAMA Neurology,
Nancy Monson, Ph.D., and colleagues at the University of Texas
Southwestern Medical Center in Dallas concluded that some of
Copaxone’s thera-peutic benefit comes from its effect on
dysregulated B cells. However, they could not confirm that it
does so by restoring B cells’ ability to produce cytokines, as
some theorize. (Cleveland Plain Dealer, ClinicalTrials.gov, Fox
News, HCP Live, PubMed)
--- End Quote ---
#Post#: 970--------------------------------------------------
(Abst.) Equivalence of generic glatiramer acetate in MS:
clinical trial
DIR By: agate
Date: October 13, 2015, 12:59 pm
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The generic glatiramer acetate is said to be the equivalent of
Copaxone.
From PubMed, October 13, 2015:
--- Quote ---
> JAMA Neurol. 2015 Oct 12:1-9.
>
> Equivalence of Generic Glatiramer Acetate in Multiple
Sclerosis: A Randomized Clinical Trial
>
> Cohen J1, Belova A2, Selmaj K3, Wolf C4, Sormani MP5, Oberyé
J6, van den Tweel E6, Mulder R6, Koper N6, Voortman G6, Barkhof
F7; Glatiramer Acetate Clinical Trial to Assess Equivalence With
Copaxone (GATE) Study Group.
>
> Author information
>
> 1Mellen Center for Multiple Sclerosis Treatment and Research,
Cleveland Clinic, Cleveland, Ohio.
> 2Functional Diagnostics, Research Institute of Traumatology
and Orthopedics, Nizhniy Novgorod, Russian Federation.
> 3Neurology Center Lodz, Lodz, Poland.
> 4Lycalis sprl, Brussels, Belgium.
> 5Department of Health Sciences, University of Genoa, Genoa,
Italy.
> 6Synthon BV, Nijmegen, the Netherlands.
> 7Image Analysis Center, Department of Radiology and Nuclear
Medicine, VU University Medical Center, Amsterdam, the
Netherlands.
>
> IMPORTANCE:
>
> The patents for the first approved treatments for
relapsing-remitting multiple sclerosis are expiring, creating
the opportunity to develop generic alternatives.
>
> OBJECTIVE:
>
> To evaluate in the Glatiramer Acetate Clinical Trial to Assess
Equivalence With Copaxone (GATE) study whether generic
glatiramer acetate (hereafter generic drug) is equivalent to the
originator brand glatiramer acetate (hereafter brand drug)
product, as measured by imaging and clinical end points, safety,
and tolerability.
>
> DESIGN, SETTING, AND PARTICIPANTS:
>
> Randomized, multicenter, double-blind, active and
placebo-controlled phase 3 trial. The setting included academic
medical centers and clinical practices.
>
> Participants were patients with relapsing-remitting multiple
sclerosis 18 to 55 years old with at least 1 relapse in the
prior year and 1 to 15 gadolinium-enhancing brain magnetic
resonance imaging lesions. They were randomized between December
7, 2011, and March 21, 2013. The last participant completed
follow-up December 2, 2013.
>
> INTERVENTIONS:
>
> Participants were randomized 4.3:4.3:1 to receive generic
glatiramer acetate (20 mg), brand glatiramer acetate (20 mg), or
placebo by daily subcutaneous injection for 9 months.
>
> MAIN OUTCOMES AND MEASURES:
>
> The primary end point was the total number of
gadolinium-enhancing lesions during months 7, 8, and 9.
Additional end points included other magnetic resonance imaging
parameters, annualized relapse rate, and Expanded Disability
Status Scale score. Safety and tolerability were assessed by
monitoring adverse events, injection site reactions, and
laboratory test results.
>
> RESULTS:
>
> In total, 794 participants were randomized and treated with
generic drug (n = 353), brand drug
(n = 357), or placebo (n = 84). The
estimated mean numbers of gadolinium-enhancing lesions with
generic drug and brand drug were lower than with placebo (ratio,
0.488; 95% CI, 0.365-0.651; P < .001), confirming
study sensitivity. For gadolinium-enhancing lesions, the
estimated ratio of generic drug to brand drug was 1.095 (95% CI,
0.883-1.360), which was within the predefined equivalence margin
of 0.727 to 1.375.
>
> The incidence, spectrum, and severity of reported adverse
events, including injection site reactions, were similar in the
generic drug and brand drug groups.
>
> CONCLUSIONS AND RELEVANCE:
>
> As treatment for relapsing-remitting multiple sclerosis,
glatiramer acetate generic drug and brand drug had equivalent
efficacy, safety, and tolerability.
--- End Quote ---
The abstract can be seen here
HTML http://www.ncbi.nlm.nih.gov/pubmed/26458034.
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