The European Commission Has Revoked The Centralized Marketing Authorizations For Generic Versions Of Biogen's Tecfidera (Dimethyl Fumarate) Held By Accord, Mylan, Neuraxpharm, Polpharma And Teva
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The European Commission has withdrawn marketing authorizations for generic versions of Biogen's multiple sclerosis drug Tecfidera, which is protected until February 3, 2025. This affects generics by Accord, Mylan, Neuraxpharm, Polpharma, and Teva. Biogen has taken legal steps to enforce its market exclusivity and confirms it can supply the entire European market with Tecfidera.
December 19, 2023 | 12:38 pm
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POSITIVE IMPACT
Biogen retains exclusive rights to market Tecfidera in the EU until 2025, as the European Commission revokes authorization for generic competitors. Biogen is prepared to meet the full demand in the European market.
The revocation of marketing authorizations for generic versions of Tecfidera by the European Commission is a significant positive development for Biogen. It eliminates immediate generic competition in the EU, potentially leading to sustained revenues from Tecfidera sales. The company's preparedness to supply the market reinforces its position. This news is likely to be viewed positively by investors and could lead to a short-term increase in Biogen's stock price.
CONFIDENCE 90
IMPORTANCE 85
RELEVANCE 90
NEGATIVE IMPACT
Teva Pharmaceutical Industries is impacted by the European Commission's decision to revoke marketing authorizations for generic versions of Tecfidera, which includes Teva's generic product.
Teva Pharmaceutical Industries, as one of the companies affected by the revocation of marketing authorizations for generic versions of Tecfidera, may experience a negative impact on its potential revenue from the sale of its generic version in the EU. This could be seen as a setback for Teva and may negatively influence its stock price in the short term as the company will have to adjust its strategy in the EU market.
CONFIDENCE 85
IMPORTANCE 75
RELEVANCE 70