FDA issues guidance that could make it easier for EpiPen rivals to come to market
FDA on Tuesday announced guidance seeking to change that, potentially streamlining a path to market for generic copies of complex medicines like the EpiPen and others.
FDA on Tuesday announced guidance seeking to change that, potentially streamlining a path to market for generic copies of complex medicines like the EpiPen and others. The guidance says that generic copies with some design differences may be approved as substitutable products, as long as those differences do not affect patients' ability to use the product the way it is intended. "Those design differences might correlate with different instructions for use of the two products," said FDA Commissioner Scott Gottlieb. "Under this guidance, so long as the generic applicant is able to demonstrate with data, where appropriate, that differences in design of the generic product do not affect the clinical effect or safety profile when the generic is substituted for the branded product, the generic product can be approved as a competitor to the branded drug where all other requirements for generic approval are met," Gottlieb added. The agency is also seeking to clarify guidelines on what constitutes "sameness" between generic and branded medicines.