- The FDC must target a tangible unmet need and improve the competitive profile of the parent brand. Ideally this means that the FDC:
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Has proven to be superior to each molecule separately |
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Has proven to be superior to other FDCs on the market |
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Has proven to be superior to the free association of both molecules |
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If the above is not the case, the FDC drug must be attractive to critical stakeholders for other reasons (price, compliance, convenience,...) |
- Where possible, the FDC should expand the scope of the molecule into new indications or new patient populations
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- The FDC must gain patent protection and/or market exclusivity and where possible extend the protected life of the parent brand franchise
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| In short, before developing your FDC drug, you need a positive answer to four questions: |
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- Does the FDC meet an unmet need in the market?
- Does the FDC fit with day-to-day treatment practice?
- Will the FDC provide me with a competitive advantage?
- Will I be able to establish a strong protection for my FDC?
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| If the answers to any of the above questions is no, you’d better think twice! |