Planning for 505(b)2 Commercial Success

Planning for 505(b)2 Commercial Success

Unlike generics and biosimilars, 505(b)2 regulatory products likely involve a unique claim. While 505(b)2 asset approval relies on reference product core clinical program data, ideal 505(b)2 candidates can include: Drugs with new indications Drugs with changes in dosage form, strength, formulation, ...
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