FDA CRL - Eli Lilly And Company

The FDA issued a Complete Response Letter (CRL) to Eli Lilly and Company regarding its Biologics License Application (BLA 761215/Original 2) for Rezvoglar (insulin glargine-aglr) injection, submitted December 17, 2020, and received December 18, 2020. The application sought licensure as an interchangeable biosimilar to U.S.-licensed Lantus. The primary reason for the FDA's inability to approve the application in its present form is regulatory, specifically concerning section 351(k)(6) of the Public Health Service Act. This section precludes an interchangeability determination for a second or subsequent biological product until the exclusivity period for the first interchangeable product has expired. Therefore, approval for interchangeability for Rezvoglar is currently not possible due to existing exclusivity.

The FDA also reserved comments on the proposed labeling, carton, and container labeling, indicating these areas would require attention in a future submission. For any resubmission, Eli Lilly is required to provide a comprehensive safety update. This update must detail any significant changes in the safety profile, include new nonclinical and clinical study data, present combined safety data with original BLA data, compare adverse event frequencies, and provide case report forms and narrative summaries for serious adverse events or study discontinuations. Updated exposure information and a summary of worldwide safety experience, including foreign labeling translations, are also necessary.

Eli Lilly must address these deficiencies and resubmit the application within one year or request an extension. The product cannot be legally marketed until written approval is granted, and the company may request a meeting to discuss the necessary steps for approval.