16 July 2019 - Republican Mike Kelly (R-PA) sent a letter Tuesday to US FDA Acting Commissioner Ned Sharpless questioning why insulin, which has seen dramatic price increases, is not considered a complex generic drug.

If FDA were to consider insulin a complex generic, like some other peptides, drugmakers would only need to submit an abbreviated new drug application (ANDA) to win approval for a copycat product, rather than a 505(b)(2) application, which only partly relies on the reference product. And coming next March, any follow-on insulin products will need to be approved as biosimilars.

Kelly points to an October 2017 FDA draft guidance on ANDAs for certain peptide products, questioning why insulin was not included in the guidance and wondering if there are “safety, efficacy or statutory barriers to its inclusion.”

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