As insulin products continue to remain unaffordable for many, the US Food and Drug Administration (FDA) on 13 May will hold a day-long public meeting to discuss access to insulin and issues related to the development and approval of competitor products, including biosimilar and interchangeable insulin products.
"We’re already seeing robust activity among sponsors seeking to bring forward biosimilar copies of insulin. The framework for demonstrating that these insulin products are interchangeable should also be efficient and achievable," outgoing FDA Commissioner Scott Gottlieb said.
Part of the reason that FDA is holding this meeting is to discuss the transition of certain biological products—including insulin products, insulin mix products and insulin analog products—that were initially approved under new drug applications (NDAs) but will be deemed to be a license for the biological product under section 351 of the Public Health Service Act
“After the March 23, 2020, transition, insulin products that will be deemed to be licensed under the PHS Act will be able to act as reference products for proposed biosimilar or interchangeable insulin products. There are currently no approved prescription insulin products that can be substituted at the pharmacy level,” FDA said.
As far as why FDA is holding this public hearing, the agency said it’s looking for input from patients, families, healthcare providers and others who live with diabetes or care for someone with diabetes “about the challenges and opportunities FDA should consider as we prepare for the submission and review of applications for biosimilar and interchangeable insulin products.”
Manufacturers can also provide input on the development process for biosimilar and interchangeable insulins. In particular, FDA is seeking input on scientific standards for evaluating biosimilarity and interchangeability. Specific questions include:
- “What considerations should FDA take into account when evaluating data and other information submitted by an applicant, including from analytical and clinical studies, to determine whether an insulin product is biosimilar to a reference product?
- What considerations should FDA take into account when evaluating data and other information submitted by an applicant, to determine whether an insulin product is interchangeable with a reference product?
- Do certain insulin products, for example, those that include use in insulin pumps for continuous subcutaneous infusion among the approved uses or those approved with over-the-counter marketing status, raise unique scientific considerations?
- What factors should FDA consider when evaluating a proposed biosimilar or interchangeable insulin product if the reference product raises such considerations?
- Are there additional factors FDA should evaluate for interchangeable insulin products, which may be substituted at the pharmacy for the reference product without the involvement of the prescriber?”
FDA is also interested in hearing from patients on their experiences with insulin products and how to better effectively communicate and promote awareness of biosimilar and interchangeable insulin products.
The push from FDA on insulin competition follows work by Congress to understand why insulin costs so much.
The House Energy & Commerce committee in January sent letters
to the three insulin manufacturers serving the US: Eli Lilly, Novo Nordisk and Sanofi, seeking more information on the root causes of the rising cost of insulin. And on Monday, Rep. Diana DeGette (D-CO) Tom Reed (R-NY) introduced a bill
that aims to make certain FDA guidance on the 2020 deemed to be a license transition into law.
Federal Register Notice