FDA to hold hearing on new interchangeable insulin policy

FDA will hold a public hearing May 13 to seek comments on its plan to transition regulation of insulin products to the BLA pathway. While the change will afford insulin biosimilars an easier route to the market and allow the approval of interchangeable insulin products, some lawmakers and stakeholders have argued FDA's implementation plan will delay biosimilar insulin applications.

Under an agency plan outlined in December, insulin products approved under NDAs will be deemed to have been approved under BLAs on March 23, 2020 (see "FDA Biosimilars Policies Will Bring Interchangeable Insulin to Market"). ...