The 505(b)(2) regulation offers an attractive pathway to cheaper and faster new drug development, particularly to a manufacturer with experience in developing generic products. It involves making significant changes to an existing FDA approved product, called reference product, to create a new product with its own indication, formulation, population, and/ or other differences that need to be supported with clinical studies. A major advantage of this pathway is that it allows a sponsor to rely, at least in part, on the FDA’s findings of safety and/or effectiveness for a previously approved drug, thereby reducing the number of clinical trials required for approval. The biggest incentive to develop 505(b)(2) products is 3-5 years of market exclusivity, depending on the extent of change to the previously approved drug and type of clinical data included in the approval application (NDA). However, like all drug development strategies, 505(b)(2) pathway requires careful consideration and planning taking into account all the potential issues to be addressed before embarking on development. These issues include intellectual property concerns, supporting information available either from reference products or literature, the logistics of conducting clinical trials with generic-like products, market competition for approved products and business considerations for international product launch.
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