Teva files citizen petition over Copaxone
JERUSALEM — Teva Pharmaceutical Industries has filed a citizen petition with the Food and Drug Administration, hoping to keep purported generic versions of its multiple sclerosis treatment off the market, the company said Sunday.
Teva said its petition, concerning the drug Copaxone (glatiramer acetate), is based on what it called the inability to establish acceptable “sameness” due to the active ingredient’s complexity.
Similar to Sanofi-Aventis’ blood-thinning drug Lovenox (enoxaparin), the FDA approved Copaxone as a pharmaceutical drug, but its chemical complexity has led many analysts to say it should be considered more akin to a biotech drug.
Teva said it urged the FDA to require any follow-on version of the drug to undergo preclinical testing and clinical trials before winning approval, as follow-on biologics already must do.