FDA aims to drive competition on the insulin market

As part of its focus on drug prices, the Food and Drug Administration on Tuesday announced a public hearing, set for on May 13, to discuss access to affordable insulin products, as well as the scientific and regulatory issues related to the development and evaluation of biosimilar and interchangeable insulin products.

The FDA is inviting stakeholders to discuss what factors the agency should consider when evaluating data and other information submitted by an applicant, including from analytical and clinical studies, to determine whether an insulin product is biosimilar or interchangeable to a reference product.

The agency also is seeking feedback on whether certain insulin products, for example, those that use insulin pumps for continuous subcutaneous infusion among the approved uses or those approved with over-the-counter marketing status, raise unique scientific considerations that the agency should be considering when evaluating biosimilar or interchangeable insulin products.

Additionally, the FDA is seeking input from patients about their experience with insulin products.

“A robust pathway for generic competition is critical to expanding drug access and promoting public health,” said FDA commissioner Scott Gottlieb in a statement. “This is especially true for biologic medicines, which are typically complex molecules produced by living cells, and are increasingly the backbone of modern therapy.”

In 2010, Congress, through the Biologics Price Competition and Innovation Act, gave the FDA the authority to implement a pathway for approval of biosimilar and interchangeable products, to open biologics to competition, ultimately providing more treatment options, increasing access to lifesaving medications and potentially lowering health care costs.

Gottlieb said that the FDA recently took steps to implement Congress’s direction to transition certain biological products currently approved as drugs under the Federal Food, Drug and Cosmetics Act to be licensed as biologics under the Public Health Act, making them subject to biosimilar competition.

“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," Gottlieb said. "We believe the biosimilar pathway will enable a more robust route for developing lower-cost copies of insulin, including products that are fully interchangeable with branded insulins."