Biogen secures Tecfidera exclusivity in EU until early 2025

MRI scan, brain

Biogen secures Tecfidera exclusivity in EU until early 2025

Published: Dec 20, 2023

By Tristan Manalac


The European Commission has revoked the centralized marketing authorization for the generic versions of Biogen’s multiple sclerosis therapy Tecfidera (dimethyl fumarate), the company announced on Tuesday.

The EC’s directive covers generic dimethyl fumarate products from companies such as Teva, Mylan, Accord, Polpharma and Neuraxpharm, while affirming Tecfidera’s exclusive marketing protection until February 3, 2025.

Biogen in a statement said it “welcomes” the EC’s decision, which upholds data exclusivity and marketing protection laws in the EU. “Those laws are essential to protecting innovation,” according to the company.

Tecfidera “is the only dimethyl fumarate treatment for multiple sclerosis that may be lawfully placed on the market for sale in the EU until that date,” Biogen indicated in its announcement, adding that it has already taken legal steps to protect its market protection rights for Tecfidera in the region.

Biogen contends that it has enough supply of Tecfidera to cater to the entire European market.

Tecfidera is an oral drug that won the FDA’s approval in March 2013 for the treatment of relapsing forms of multiple sclerosis. Its mechanism of action is not well understood but might exert its therapeutic effects by suppressing the expression pro-inflammatory genes, while altering the properties of immune cells to become more anti-inflammatory and preventing their infiltration into the central nervous system.

Despite hitting the market around a decade ago, Tecfidera remains one of Biogen’s top assets. In the third quarter of 2023, the drug brought in $239.5 million in revenue, cementing its place among the company’s best-selling multiple sclerosis therapies, just behind Tysabri (natalizumab).

For Biogen, Tuesday’s win over generics in Europe is a welcome deviation from its patent case in the U.S. In June 2020, U.S. District Judge Irene Keeley gutted Biogen’s key patent protecting Tecfidera, which was originally set to expire on February 2028, Fierce Pharma reported at the time.

The pharma appealed the decision but in November 2021 an appellate court took Keeley’s side, agreeing that Biogen’s crucial patent was invalid.

Biogen’s final defeat came in October 2022, when the U.S. Supreme Court denied to hear its case.

According to medicine information platform, there are several generic dimethyl fumarate products available in the U.S. manufactured by companies including Accord Healthcare, Alkem Labs, Amneal and Mylan.

Source: BioSpace