Following the recent news that Biogen’s Vumerity (diroximel fumarate) was granted marketing authorization by the European Commission for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS), GlobalData, a leading data and analytics company, expects Vumerity to claim market share in Europe both from new RRMS patients starting on an oral fumarate treatment, as well as those who cannot tolerate the gastrointestinal side effects of its predecessor, Tecfidera. As such, Vumerity will likely have moderate, yet significant uptake globally, likely reaching blockbuster status by 2027.

Sarah Elsayed, Neurology Analyst at GlobalData, comments: “This approval comes just in time to help Biogen offset anticipated sales erosion in the multiple sclerosis (MS) space as the company’s blockbuster drug, Tecfidera (dimethyl fumarate), approaches loss of patent protection in the European markets in 2024.”

Having demonstrated more favorable gastrointestinal (GI) tolerability and comparable efficacy to that of Tecfidera, Vumerity was first approved in the US in October 2019. Recently, several cost-effective generic versions of Tecfidera became available in the US market following the drug’s patent expiry in 2020.

Elsayed continues: “Some key opinion leaders (KOLs) interviewed by GlobalData stated that, although Vumerity has overtaken Tecfidera since its launch in the US, particularly in the new RRMS patients, Vumerity has struggled to contend with the heavy competition from generic oral fumarates.”

KOLs noted that in the US generics currently represent the highest share of prescriptions within this therapeutic class, as most MS patients do not find the GI side effects of dimethyl fumarate to be a major issue.

Elsayed adds: “In Europe, Biogen is likely aiming to expand its existing share in the fumarate class, thus mitigating the imminent risk of Tecfidera generic infiltration in 2024. In line with its current pricing strategy in the US, GlobalData anticipates Vumerity will have a much lower price tag than Tecfidera in the European markets. This will make it a more enticing option upon launching in those markets.”

Although Vumerity is expected to perform well, given the limited advantages of the drug over dimethyl fumarate, as well as the heavy competition among the oral MS therapies, it will likely be difficult for the drug to replicate the impressive growth trajectory of Tecfidera, which had peak global sales of *$4.4 billion in 2019.

*Data taken from GlobalData’s report: Multiple Sclerosis – Global Drug Forecast and Market Analysis to 2028