BeneFIX (Pfizer) is an recombinant factor IX (rfIX) therapy indicated for the control and prevention of bleeding in hemophilia B. The recombinant protein is produced using the Chinese hamster ovary cell line, and no human or animal proteins are added during the cell culture, purification, or formulation processes. BeneFIX was first commercialized by Pfizer, and was formerly distributed by Baxter in Europe and Takeda in Japan, although Pfizer has since regained sole marketing rights to the drug.
It was the first-to-market recombinant therapy approved for hemophilia B, and faced little competition until the approvals of Rixubis (rfIX; Shire) and Alprolix (rfIX Fc fusion protein; Sanofi/Bioverativ) in 2013 and 2014, respectively. Importantly, both competing drugs are approved for routine prophylactic use in the US, whereas BeneFIX is not. However, Pfizer has conducted a trial supporting the off-label use of BeneFIX as a once-weekly prophylactic regimen.
LIST OF FIGURES
8 Figure 1: BeneFIX for hemophilia – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of BeneFIX for hemophilia
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of BeneFIX for hemophilia
12 Figure 4: BeneFIX sales for hemophilia across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
5 Table 1: BeneFIX drug profile
7 Table 2: BeneFIX pivotal trial data in hemophilia
13 Table 3: BeneFIX sales for hemophilia across the US, Japan, and five major EU markets, by country ($m), 2016–25
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