Author Topic: Generic Copaxone probably as good as the brand-name  (Read 242 times)

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Offline agate

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Generic Copaxone probably as good as the brand-name
« on: October 07, 2014, 02:52:52 pm »
From the MS Research Roundup, MS Discovery Forum, October 3, 2014:

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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)
« Last Edit: October 13, 2015, 08:53:11 am by agate »
MS Speaks--online for 13 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

Offline agate

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The generic glatiramer acetate is said to be the equivalent of Copaxone.
From PubMed, October 13, 2015:

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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.

The abstract can be seen here.
MS Speaks--online for 13 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

Offline agate

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The US National MS Society has issued some information about a second generic version of glatiramer acetate (Copaxone), put out by Mylan:

https://www.nationalmssociety.org/About-the-Society/News/FDA-Approves-Two-New-Generic-Forms-of-Copaxone%C2%AE-(G
MS Speaks--online for 13 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.