Table IV.

Comparison of Plasma‐Derived Monoclonal‐Antibody Purified and Recombinant Anti‐Factor VIII Products

	Plasma‐derived	Recombinant	Comparisona
Efficacy	Excellent	Excellent	Equivalent
Safety
Antibody provocationb	37% 31	36% 31	Equivalent
Microbiological	Possible	Unlikely	Recombinant
Ease of reconstitution	Very good	Very good	Equivalent
Ease of administration	Very good	Excellent	Recombinantc
Cost and affordability	Excellent	Very good	Plasma‐derived
Availability/accessibilityd	Good	Good	Equivalent

^aThe comparison refers to the differential evaluation of plasma‐derived and recombinant anti‐factor VIII products. The favored product is indicated after considering the risks, benefits, cost and alternatives of plasma‐derived and recombinant anti‐factor VIII products for each characteristic.

^bHigh‐titer inhibitor (>5 BU)

^cRecombinant anti‐factor VIII products are considered superior over plasma‐derived concentrates in terms of ease of administration due to the lower reconstitution volumes and therefore smaller volume for infusion and the recommended rate of infusion.

^dOver 2 billion units of plasma‐derived factor VIII concentrate and more than 3 billion units of recombinant products are available world‐wide yet over 80% of the world's hemophilia patients receive inadequate or no replacement therapy.

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