About Multiple Sclerosis Foundation

Home > Learn About Multiple Sclerosis > News > Teva Tries to Combat Generic Drug Competition

Teva Tries to Combat Generic Drug Competition


Teva Pharmaceuticals has filed a citizen’s petition with the Food and Drug Administration (FDA) in a new effort to stop generic competition for its Copaxone drug. Copaxone is a medical injection that is used to reduce the frequency of relapse in patients with MS. Last year, the courts invalidated key Teva patents for the drug, opening the door for generic competition this year.

The citizen’s petition argues that “it would be contrary to the public’s health and welfare to approve a purported generic glatiramer acetate product that, based on current analytical technologies at best, can be shown to be similar, but clearly not the same as Copaxone.” Glatiramer acetate is the active ingredient in Copaxone. Teva’s position is that any potential generic version of Copaxone should use the same gene expression markers and biological pathways to demonstrate it has the same safety and efficacy as its drug. The company also argues any generic versions of the drug should be evaluated through pre-clinical testing and full-scale, placebo-controlled clinical trials with measured clinical endpoints, such as relapse rate in patients with relapsing forms of multiple sclerosis to establish safety, efficacy, and immunogenicity.

The FDA said the petition “will allow others the opportunity to comment and participate in the decision-making process, will allow Teva the opportunity to comment publicly on the views and opinions of others, and will facilitate creation of an administrative record on which the agency may base future decisions” regarding applications seeking approval for generic Copaxone products.

  Support the MSF
Supporting MSF's programs to help make "a brighter tomorrow" has never been easier.
make a donation 

  Learn About MS
Common symptoms of MS include fatigue, weakness, spasticity, balance problems, bladder and bowel problems, numbness, vision loss, tremors and depression.
learn more 


Unless otherwise specified, all medical content is compiled by MSF staff and reviewed for accuracy by a member of our Medical Advisory Board.

The MSF strives to present clear and unbiased information. This site is partially funded through a grant from Bayer Healthcare, LLC.

© Copyright 2000-2013 Multiple Sclerosis Foundation - All Rights Reserved