FDA Is Urged To Make All Biosimilar Insulins Interchangeable

Demonstrating biosimilarity for insulin products in the US “should automatically generate an interchangeability designation”, according to comments submitted to the US Food and Drug Administration by Biocon as part of a consultation revolving around increasing access to and facilitating development of biosimilar and interchangeable insulins.

Under FDA guidance, on 23 March 2020, all FDA-approved insulins will switch from new drug application (NDA) status to 351(a) Biologics License Application (BLA) status – the pathway for original biologic applications, as opposed to the 351(k) BLA pathway for biosimilars – including ‘follow-on’ insulin products already approved under the 505(b)(2) NDA pathway