Interchangeable insulins: FDA holds public meeting
FDA convened on Monday a public meeting to hear from drug companies and stakeholders about the future of insulin biosimilars.
FDA convened on Monday a public meeting to hear from drug companies and stakeholders about the future of insulin biosimilars. Acting FDA Commissioner Ned Sharpless started the meeting by noting that insulin competition is limited, with only three follow-on insulin products approved since 2015, and that list prices have increased substantially in the past 10 years. The agency issued Friday final guidance on Friday on what studies need to be conducted to establish interchangeability, plus earlier guidance addressed transitioning certain biologics previously regulated as drugs to help companies seeking to bring insulin competitors to market. At the meeting, some industry and academic speakers noted how patients switch between various insulin products, which led to the question of why there should be two distinct categories for insulin biosimilars and interchangeable insulins. Additionally, Mylan's Abhijit Barve highlighted the need for streamlined approaches to developing interchangeable insulins.