The handling of marketed product has become a key consideration for clinical programs with material implications for overall trial costs and logistics. A marketed drug may be required as a comparator in a randomized clinical trial for a new chemical entity or biosimilar study, or in the case of an investigational add-on therapy to existing regimens.
Retinal disease studies offer an excellent proxy for the clinical development industry as a whole regarding the handling of marketed product because there are readily available standard-of-care therapies—namely, anti-VEGF agents Lucentis (ranibizumab injection) and Eylea (aflibercept)—which are commonly used in human research.
Clinical programs in subjects with wet age-related macular degeneration, diabetic macular edema or retinal vein occlusion frequently require one of these anti-VEGF drugs as comparators in non-inferiority or superiority designs, or in combination with other investigational agents. For these reasons, Lucentis and Eylea will be considered the reference marketed drugs throughout this paper, but the considerations, approaches and lessons apply broadly to other agents and therapy areas. Additionally, the term “drug” or “marketed drug” is used throughout this paper to mean a pharmaceutical, biologic, combination product or other therapeutic agent.
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