Biogen holds onto Tecfidera market in Europe for a little longer

2023-12-19

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Dive Brief:

The European Commission has revoked the approvals for five generic versions of Biogen’s multiple sclerosis medicine Tecfidera, ensuring the once top-selling drug’s market position there is maintained through early 2025.

The EC’s decision follows a judgment by the Court of Justice of the European Union earlier this year that favored Biogen, and the EC’s subsequent determination Tecfidera was entitled an additional year of exclusivity for a pediatric indication.

In Biogen’s statement Tuesday, the company said it had sufficient supplies of Tecfidera to supply “the entire European market.” Sales of the drug outside of the U.S. totaled about $570 million through the first nine months of 2023.

Dive Insight:

Tecfidera was for years Biogen’s flagship product, accounting for about one-third of the company’s revenue as recently as 2020.

The expiry of key patents and entry of lower-cost generic rivals in the U.S., Brazil and certain European countries have rapidly eroded the drug’s market position, however. Sales fell from $4.4 billion in 2019 to $1.4 billion last year.

Even so, Biogen’s faltering business elsewhere has meant Tecfidera still accounts for a meaningful share of revenue — about 14% through the first nine months of 2023 on the back of ex-U.S. sales. (Tysabri, another multiple sclerosis medicine, is now Biogen’s top-seller, but could soon face biosimilar competiton of its own.)

In its recent third quarter report, Biogen noted that, despite the EU court decision and additional year of market protection for Tecfidera, generics remained on the market in some European countries. The company said Tuesday that branded Tecfidera is the only version of the drug that “may be lawfully placed on the market for sale in the EU” until Feb. 3, 2025.