The Issues Surrounding Generic Versions of MS Drugs

In the Winter/Spring 2014 issue of MSAA’s magazine, The Motivator, MSAA introduced the concept of biosimilar drugs, defining what they are and how they may impact future treatment options for individuals with multiple sclerosis (MS). The feature article titled “Biosimilars: Approval on the Horizon” described biosimilars as drugs that are “highly similar” to the approved biologic medications.

Biologic medications are derived from living cells. Six of the 10 disease-modifying therapies (DMTs)currently approved by the Food and Drug Administration (FDA) for the long-term treatment of MS fall into this classification of biologics. These include all but one of the self-injected medications (Avonex®, Betaseron®, Extavia®, and Rebif®), as well as those given via intravenous infusion – Novantrone® (mitoxantrone) and Tysabri® (natalizumab).

Biosimilars are drugs that are designed to be as close as possible to an existing biologic drug. However, since biologic drugs are derived from living cells, they cannot be identical to the original biologic medication. For this reason, biosimilar drugs must prove that they are equally safe and effective as the original drug in order to gain FDA approval, most likely through clinical trials. The hope is that when biosimilar medications have proven their safety and efficacy, and are able to enter the market, they will provide a less-expensive treatment option.

The other four FDA-approved DMTs for MS include the self-injected medication, Copaxone® (glatiramer acetate), as well as three oral medications: Aubagio® (teriflunomide), Gilenya® (fingolimod), and Tecfidera™ (dimethyl fumarate). While these are not considered by the FDA to be biologics, they do have complex molecular structures that may be difficult to replicate. A different pathway to approval for generic versions of these non-biologic drugs has been established by federal legislation.

The FDA is currently reviewing and may rule shortly on applications for a generic version of Copaxone, which is manufactured by Teva Pharmaceuticals. Other pharmaceutical companies, including Mylan® and Sandoz (a Novartis company), have made formal applications to the FDA for approval of their generic forms of Copaxone.

Teva Pharmaceuticals contends that their drug (Copaxone) is too complex for another manufacturer to make an identical drug. Therefore, Teva believes that any new (generic) drug should be tested in clinical trials with MS patients to assure its safety and efficacy. This could mean more studies to be conducted with MS patients, adding additional time to the approval process. The generic petitioners, Mylan and Sandoz, each believe they can demonstrate their drugs’ purity, safety, and effectiveness to the FDA without the need for clinical trials with MS patients.

A letter was written to the FDA by the MS Coalition, a group of eight major MS organizations (including MSAA) who work together for the benefit of the MS community. In this letter, the MS Coalition expressed its concerns regarding potential safety and efficacy issues with MS generic drugs. The MS Coalition also discussed these same issues during a conference call with the FDA. MSAA appreciates the FDA’s willingness to discuss these issues and to give our concerns due consideration.

MSAA recognizes that the FDA has the legislative responsibility and greater expertise to rule on these issues. The MS community depends on the FDA to decide on the value and potential risks of generic forms of MS drugs, including Copaxone. Generic versions of Copaxone are still under FDA review, although a decision is expected very soon. MSAA and the MS Coalition have emphasized our position that patient safety and drug efficacy are and must continue to be of the utmost importance when evaluating generic MS medications.

Written by Jack Burks, MSAA Chief Medical Officer and Robert Rapp, MSAA Chief Operating Officer
Edited by Susan Wells Courtney