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# Stakeholders Speak on Insulin Supply
- URL: https://www.fdaweb.com/stakeholders-speak-on-insulin-supply/
- Published: 2019-05-29T12:00:00.000Z
- Updated: 2026-09-15T01:29:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144208

An FDA 5/13 public [meeting](https://www.regulations.gov/contentStreamer?documentId=FDA-2019-N-1132-0116&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) on the future of insulin biosimilars heard from stakeholders representing many different perspectives. Mylan head of global clinical research **Abhijit Barve** said any “additional requirements not based on risk or clinical relevance will only be a barrier to development” of biosimilar insulins. “In fact,” he said, “we have an opportunity to streamline development by having an integrated design that addresses both biosimilarity and interchangeability in a single study as indicated in the final interchangeability guidance.” Barve also stressed the need for additional communications on biosimilars and their approval process.

Lilly vice president **Sherry Martin** said her company “strongly supports FDA’s efforts to promote innovation, competition, and access with regard to insulin products.” She said Lilly agrees with FDA that a robust showing of biosimilarity is the first step in demonstrating interchangeability. She said the company recommends that the agency develop the requirements for interchangeable insulin products based on a case-by-case assessment of the strength of the biosimilarity data. Beyond biosimilarity, Martin said, interchangeability requires evidence to ensure safe substitution in the absence of prescriber oversight.

“In the near term,” Martin said, “we believe that FDA should focus on biosimilarity and interchangeability of insulins in current presentations. And in the future, interchangeability for biosimilar insulins within a connected ecosystem should be assessed separately. Ideally, this could be part of FDA’s upcoming guidance on presentation-related interchangeability issues.”

The Association for Accessible Medicine’s **Christine Simon** told the FDA panel the “insulin market in the United States is a direct reflection of issues facing biosimilars more broadly. The current insulin market lacks competition to the detriment of patient access and health and has been characterized as a public health crisis. The combination of regulatory challenges, over-patenting to stave off competition, and anti-competitive rebating and contracting tactics by brand firms are some of the reasons for this lack of competition.”

She said her trade group supports the FDA guidance on interchangeability, and particularly its streamlined data and study design requirements that allow flexibility and use of global comparator products to support applications.

“Contrary to all-too-prevalent misinformation campaigns around the safety and efficacy of biosimilars driven by some brand manufacturers,” Simon said, “stakeholders do not need to wait for interchangeable biologics to use biosimilars with their patients. Significant evidence exists that a physician-led transition from a reference product to a noninterchangeable biosimilar does not result in a loss of safety or efficacy…. Availability of biosimilar insulin is likely to increase patient access and savings. To that end, in terms of the agency’s educational efforts on biosimilar insulin, we would like you to continue emphasizing that a transition from a reference product to a noninterchangeable biosimilar will not result in changes to safety or effectiveness.”

**Marjana Marinac**, a JDRF (formerly Juvenile Diabetes Research Foundation) staff person, spoke of the type of information that needs to be communicated about biosimilars, including what a biosimilar or interchangeable insulin is, how to know what the insulin is biosimilar for or interchangeable with, an explanation of how these types of products are named to avoid administration errors, and how patients or providers can get more help or information. “We foresee that patients may receive information from many different sources,” she said, “so this should be taken into consideration as communication and education strategies are developed. Certainly, some of this information should be included in patient labeling for products, but we also need to ensure that all healthcare providers caring for patients taking insulin are fully informed and have resources available…. All of this points to the need for a comprehensive and continuous education campaign.”

Finally, the American Diabetes Association’s former chief scientific and medical officer **Robert Ratner** said that rather than needing more insulins, what is needed is better insulins and insulins that are more predictable, reliable, accessible, and cheaper.

He said that people with diabetes “want to know that the insulin they take today will work the same way tomorrow and the day after that and the day after that…. You want to be able to demonstrate reproducibility of a given dose in a given patient…. So having more insulins on the market isn’t necessarily going to help things; it’s going to confuse things.”