Following the entry of generic versions of Tecfidera, the drug’s revenue dropped from peak sales of $4.4bn in 2019 to $1.4bn in 2022. Image Credit: PictureDesignSwiss / Shutterstock.

The EC has ruled in favour of Biogen and revoked the centralised marketing authorisations for generic versions of Tecfidera (dimethyl fumarate) held by multiple companies.

These companies include Accord Healthcare, Mylan, Neuraxpharm, Polpharma and Teva Pharmaceuticals.

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Additionally, the EC granted the drug full data and marketing protection until 3 February 2025. Following the decision, Biogen initiated legal action to defend its market protection rights, as per a 19 December press release.

Although the exact mechanism of action is Tecfidera is not known, BG-12, the active component of Tecfidera, suppresses inflammatory response and protects against nerve cell death. The drug was approved by the EC as a first-line oral treatment for people with relapsing-remitting multiple sclerosis (RRMS), a common form of multiple sclerosis (MS).

In 2020, Mylan launched a generic version of Tecfidera in the US, and since then other companies have launched generic versions of the drug. The entry of the discounted generics led to a sharp decline in Tecfidera’s revenue. It dropped from generating peak sales of $4.4bn in 2019 to $1.4bn in 2022, with the US sales of the drug being $417.7m in 2022, as per the company’s financials. The EC’s decision could revive the sales, which were expected to decrease to $552m in 2025, as per GlobalData’s analysis.

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Despite successful litigation in Europe, Biogen failed to fend off the generic versions of Tecfidera in the US. In 2020, federal courts in West Virginia and Delaware entered judgments invalidating Biogen’s patents and allowing generic versions of Tecfidera. Biogen lost the appeal, and the Federal Circuit affirmed the judgment of the West Virginia federal court in 2021.

MS is a high-grossing indication for Biogen, with the company having six different marketed therapies for the indication. The company is also facing generic threat for its highest-grossing MS therapy Tysabri (natalizumab). In August 2023, the US Food and Drug Administration approved the first Tysabri biosimilar developed by Sandoz.