Originally developed by Merck KGaA, Rebif was first launched in the EU in 1998, followed by launch in the US in March 2002. In 2002, Pfizer paid Merck KGaA $200m upfront to co-promote Rebif in the US, and in return, Pfizer is understood to receive an estimated 35–40% commission on sales. Rebif is administered subcutaneously three times per week compared to Avonex’s once-weekly dosing. A single-use, auto-injector device for Rebif, marketed as Rebif Rebidose for easier self-administration, was first approved in the EU in 2010 and later in the US in January 2013.
In 2002, the US Food and Drug Administration (FDA) overturned Avonex’s orphan drug exclusivity when Merck KGaA demonstrated superior efficacy for Rebif over Avonex in a six-month comparator trial. The FDA’s subsequent approval of Rebif provided an important endorsement of its clinical superiority and likely bolstered the argument that higher, more frequent doses of interferon beta provide greater efficacy.
LIST OF FIGURES
7 Figure 49: Ozanimod sales for multiple sclerosis across the US and five major EU markets, by country, 2016–25
9 Figure 50: Ponesimod for multiple sclerosis – SWOT analysis
11 Figure 51: Datamonitor Healthcare’s drug assessment summary of ponesimod for multiple sclerosis
LIST OF TABLES
5 Table 1: Rebif drug profile
6 Table 2: Rebif pivotal trial data in multiple sclerosis
12 Table 3: Rebif sales for multiple sclerosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
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