FDA approves a generic for Teva's Copaxone, bringing longstanding regulatory battles near an end

A years-long battle, with part of it going all the way to the US Supreme Court, over the ability of generic manufacturers to copy Teva Pharmaceuticals’ Copaxone (glatiramer acetate) seems to have ended with FDA’s April 16 approval of Sandoz’ abbreviated new drug application (ANDA) for a generic version. The announcement is not a big surprise; Teva (which itself is a renowned, aggressive, generics manufacturer) has been buying up small specialty pharmaceutical companies (Auspex Pharma, and, last year, Labrys Biologics) in an ongoing effort to become a branded-pharma company. It also introduced, in January 2014, a new formulation of Copaxone that reduced injections to multiple sclerosis patients to three times weekly, and according to press reports, has been able to convert approximately 70% of existing patients to the newer formulation, which will extend Teva’s control of the Copaxone brand.

A large part of the litigation over generic Copaxone had to do with its complex chemistry. Teva had filed eight citizen’s petitions to FDA, asserting that generic competitors would need to perform extensive clinical studies in order to demonstrate the bioequivalence that is the core of a generic approval. FDA deferred answering those petitions until today (maintaining that such petitions could not be addressed until an FDA action had been taken), and now has rejected Teva’s claims about testing bioequivalence.

In a 43-page response to Teva, FDA stated that “We recognize that approval of ANDAs for glatiramer acetate injection raises complicated scientific and regulatory issues, which we have carefully considered.” Nevertheless, “Based on our evaluation of all of the relevant data and other current relevant scientific information, our experience and expertise, Agency precedent, and applicable law, we find that glatiramer acetate has been adequately characterized for the purposes of approving a generic product; and we conclude that an ANDA applicant for glatiramer acetate injection can demonstrate active ingredient sameness,” provided certain technical criteria were met.

Sandoz did not immediately announce when the generic, a once-daily formulation, would be on the market; under one interpretation of prior litigation, it could happen after November. Other generic manufacturers are also in the running for an FDA ANDA approval.