Biogen bonus as generic Tecfidera approvals are pulled in EU

The European Commission has pulled marketing authorisations for generic versions of Biogen’s oral multiple sclerosis therapy Tecfidera, after concluding that the brand qualifies for additional protections in the marketplace.

Biogen said in a statement today that the decision affects centralised marketing authorisations for Tecfidera (dimethyl fumarate) generics held by Accord, Mylan (now Viatris), Neuraxpharm, Polpharma, and Teva.

The EC has “affirmed that Biogen is entitled to full data protection and marketing protection for Tecfidera,” extending protection from generic competition until 3rd February 2025, according to the company, which said it has already started litigation in the EU to defend its market protection rights.

The new decision means 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.” It also says it has sufficient Tecfidera to supply the market once the generics are no longer available.

Tecfidera was Biogen’s biggest-selling drug for several years, adding $4.4 billion to its top line in 2019, its sales peak, but contracted rapidly after losing patent protection and generated $768 million in the first nine months of this year, with around $570 million of that total from outside the US.

The company sought to limit the impact of Tecfidera competition with the launch in 2019 of Vumerity (diroximel fumarate), designed to reduce gastrointestinal side effects that have long been a recognised problem with Tecfidera.

Sales of Vumerity have never gathered much momentum, reaching $420 million in the first nine months of 2023, and the renewed lease of life in the EU for Tecfidera is a boost to Biogen’s MS franchise, which still accounts for two-thirds of its product revenues.

It’s also important given Biogen’s aborted launch of Alzheimer’s therapy Aduhelm (aducanumab) and the anticipated slow take-up of follow-up Leqembi (lecanemab), both partnered with Eisai, and the effects of increased competition in the spinal muscular atrophy (SMA) market that has stalled sales growth for blockbuster Spinraza (nusinersen).

In March, Biogen won a ruling from the European Court of Justice confirming regulatory data protection for Tecfidera until at least February 2024, but generics have nevertheless remained on the market.

At the time, the company said it would try to maintain patent protection for the drug until 2028 through the enforcement of EU patent number EP 2 653 873.