USA – FDA Updates its Thinking on Immunogenicity Studies for Insulin Biosimilars, Interchangeables

As the cost of insulin continues to force some to ration their lifesaving drugs, the US Food and Drug Administration (FDA) on Monday released new draft guidance to help sponsors bring insulin biosimilars and interchangeable products to market more quickly.

The 8-page draft offers an update to FDA’s thinking on comparative clinical immunogenicity studies and whether they are necessary to support the licensure of proposed biosimilar and interchangeable insulin products for those with Type 1 or Type 2 diabetes.

Although no companies have publicly announced their intention to win approval for an interchangeable insulin product, this guidance, along with interchangeability guidance from May, should help speed their journey to market.

Previously, FDA explains, the agency took the position that data from a comparative clinical immunogenicity study would likely be needed to evaluate the potential risk and clinical impact of immunogenicity of proposed biosimilar and interchangeable insulin products…