Generics of Tecfidera not available in Europe until at least 2025

European Commission decision supports Biogen's pursuit of market exclusivity

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by Mary Chapman |

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The European Commission (EC) has withdrawn its marketing authorizations for generic versions of Tecfidera (dimethyl fumarate), an oral therapy approved in Europe for relapsing-remitting multiple sclerosis (RRMS).

According to Biogen, which developed and markets the brand-name medication, the decision ensures Biogen will have full data and marketing protection for Tecfidera at least until Feb. 3, 2025. That means it will be the sole dimethyl fumarate MS therapy that may be marketed for sale legally in the European Union.

Generic forms of the medication that already had gained approval in Europe — which are sold by the companies Accord, Mylan, Neuraxpharm, Polpharma, and Teva — no longer will be available in the European market. Generics are medicines that are the same as the brand-name product, but usually are less expensive.

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“Biogen welcomes the actions of the European Commission, which confirm the laws governing data exclusivity and marketing protection. Those laws are essential to protecting innovation,” the company said in a press release.

The company said it has begun legal action to defend its market protection rights, and that it has sufficient inventories of Tecfidera to supply the entire European market.

Tecfidera first was approved in the U.S. in 2013 for the treatment of adults with relapsing forms of multiple sclerosis (MS), including active secondary progressive MS, relapsing-remitting MS, and clinically isolated syndrome. It was approved in Europe in 2014, but only for those with RRMS.

The delayed-release capsule medication is believed to work by reducing inflammation and oxidative stress (a type of cell damage) in the brain and spinal cord, ultimately preventing more nerve damage.

Phase 3 clinical trials DEFINE and CONFIRM

Its approvals were based mainly on data from two large Phase 3 clinical trials — DEFINE (NCT00420212) and CONFIRM (NCT00451451) — which collectively enrolled more than 2,400 RRMS patients.

In both studies, the medication demonstrated the ability to significantly reduce relapse rates and prevent the development of brain lesions. Disability progression also was delayed in the DEFINE trial. The findings continued to be sustained in a long-term extension trial in which participants were followed for about 13 years.

Generic versions of Tecfidera are drugs that show a similar safety and efficacy profile as the brand-name medication, and that have a similar behavior inside the body, reaching comparative levels in the bloodstream and being excreted at the same rate. Because they are generally sold at lower prices than the original medication, they introduce competition in the market that can  reduce healthcare costs overall.

While generics will no longer be sold in Europe until 2025, several generic formulations of Tecfidera are available for use in the U.S., where a patent protection from Biogen was deemed invalid by a U.S. district court.