Teva Claims Generic Doesn’t Match Copaxone

As part of a campaign against generic competition, Teva on Monday published data that purports to demonstrate significant differences in biological and immunological effects between its branded drug and a generic version. The research carried out on mice and not humans was conducted by Teva and genomic research company Immuneering, according to Globes.

The research focused on a generic version already being marketed in India by Natco Pharma, one of the firms expected to compete with Teva’s Copaxone in the U.S., when the patent expires and marketing approval is received.

Teva says the research results “have potential clinical ramifications” and that the study “demonstrated a predictable and therapeutically-aligned impact of Copaxone on genes associated with key immune response-related cells. This is in contrast to a significantly different and irregular impact on genes associated with these cells by the purported generic GA.”

Teva added: “The cells identified in this study included regulatory T cells (Tregs), which control immune and auto-immune responses, and myeloid lineage cells — the precursors of many immune response cells. The gene expression impact and variability of the purported generic GA indicates different biological effects of these drugs.”

Ever since the patent on Copaxone neared expiration and competition threatened, Teva has been arguing that Copaxone is a complex drug that will not be easy to replicate.

This article appeared in print on page 7 of the January 14th, 2014 edition of Hamodia.