Mylan only the first chink in Tecfidera’s armour

Mylan’s at-risk launch of a generic version of Biogen’s Tecfidera could be the beginning of the end for Biogen's cash cow. Mylan got the trucks rolling the day it received US approval, and it could keep them moving for some time. Not only has Biogen’s appeal yet to be scheduled, it could take 12-18 months for a resolution, giving Mylan plenty of time to ramp up sales. And this is just the first crack in the damn. Over 20 other challenges could follow if Biogen loses a separate challenge in the Delaware courts. These companies have ratcheted up the pressure by asking if the decision in the West Virginia court could be applied to them. Bernstein expects a ruling in the coming weeks, and if this is positive the companies could also start selling immediately. With Biogen facing the prospect of losing the drug that made up 39% of its 2019 sales, the pressure on aducanumab will be even more intense. If the Alzheimer's project succeeds its expected multi-billion-dollar sales will make the loss of Tecfidera academic, but with some analysts seeing the odds of approval at 50/50 this could be one of the industry’s most expensive coin tosses.

Biogen's top 5 products in 2026
    Annual sales ($m)    
Product Therapy category 2019 2026e CAGR Status  Patent expiry
Tecfidera Multiple sclerosis 4,433 3,003 -5% Marketed Aug 2020
Aducanumab Nootropics - 2,119 n/a Filed Dec 2035
Tysabri Multiple sclerosis 1,892 1,315 -5% Marketed Apr 2017
Spinraza Other CNS drugs 2,097 1,174 -8% Marketed Jan 2034
Avonex Multiple sclerosis 1,666 828 -10% Marketed May 2013
Source: EvaluatePharma.

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