Teva files citizen petition as it defends Copaxone patent
- Teva has submitted a citizen petition to FDA regarding biosimilar ‘sameness’ as it continues to defends its Copaxone (glatiramer acetate) patent.
- Teva’s patent for the original version of Copaxone expired on May 24. Mylan Labs has developed a biosimilar version of Copaxone, which is seen as a looming threat to Teva.
- FDA would like to open the discussion of biosimilar sameness to the public.
Teva’s strategy in the face of losing its patent on Copaxone has been introducing a new longer lasting version and also continuing to petition FDA to not approve generic versions of Copaxone without requiring a full set of clinical trials.
The latest effort -- a citizen’s petition -- provides scientific evidence regarding gene expression, immunogenicity, bioequivalence testing and other issues related to determining precise biosimilarity. Teva maintains that full-scale, placebo-controlled clinical trials should be required before generic versions of Copaxone are approved.
- Pharmaceutical Business Review Teva files citizen petition for approval of generic COPAXONE