FDA Seeks to Speed Insulin Biosimilar Approvals with New Guidance

In a move to help sponsors of insulin biosimilar applications, the FDA spelled out the data and information needed to support immunogenicity assessments for insulin biosimilars or interchangeables in a draft guidance.

In announcing the draft guidance, acting FDA Commissioner Brett Giroir highlighted the upcoming transition on March 23, 2020 of all approved New Drug Applications (NDAs) for biological products to approved Biologicals License Applications (BLAs), noting the change will mean that currently-approved insulin products can be listed as reference products for biosimilars and interchangeables products.

“The availability of approved biosimilar and interchangeable insulin products is expected to increase access and reduce costs of insulin products,” he said.