Complete Response Letter BLA 761147 (Apr 5, 2024)

Summary

This section provides feedback from the FDA regarding a Biologics License Application (BLA 761147), specifically addressing proposed labeling, proprietary name, and the requirement for a safety update. It encourages the applicant to review relevant FDA resources and guidance documents.

Key points

• The applicant must review the labeling review resources on the Prescription Drug Labeling Resources and Pregnancy and Lactation Labeling Final Rule websites.
• The applicant must review the FDA guidance for industry Labeling for Biosimilar Products.
• The applicant must resubmit the proposed proprietary name when responding to all application deficiencies.
• The applicant must include a safety update when responding to application deficiencies.
• The safety update must include data from all nonclinical and clinical studies of the product under consideration regardless of indication, dosage form, or dose level.
• The safety update must describe in detail any significant changes or findings in the safety profile and their relevance to clinically meaningful differences between the proposed biosimilar product and the U.S.-licensed reference product.
• The safety update must incorporate new safety data into the sections describing discontinuations due to adverse events, serious adverse events, and common adverse events.
• The agency reserves comment on the proposed prescribing information until the application is otherwise adequate, indicating that the current labeling is not sufficient for approval.

Cited reasons

• Inadequate Prescribing Information
• Inadequate Carton and Container Labeling
• Proprietary Name Resubmission Required
• Comprehensive Safety Update Required
• The application received a Complete Response Letter primarily due to inadequate prescribing information, carton and container labeling, and the requirement for a comprehensive safety update. The proprietary name was conditionally acceptable but its resubmission is contingent upon addressing all other deficiencies.

Recommended actions

• The applicant must review the labeling review resources on the Prescription Drug Labeling Resources and Pregnancy and Lactation Labeling Final Rule websites.
• The applicant must review the FDA guidance for industry Labeling for Biosimilar Products.
• The applicant must resubmit the proposed proprietary name when responding to all application deficiencies.
• The applicant must include a safety update when responding to application deficiencies.
• The safety update must include data from all nonclinical and clinical studies of the product under consideration regardless of indication, dosage form, or dose level.
• The safety update must describe in detail any significant changes or findings in the safety profile and their relevance to clinically meaningful differences between the proposed biosimilar product and the U.S.-licensed reference product.
• The safety update must incorporate new safety data into the sections describing discontinuations due to adverse events, serious adverse events, and common adverse events.

Deficiency summary

The application received a Complete Response Letter primarily due to inadequate prescribing information, carton and container labeling, and the requirement for a comprehensive safety update. The proprietary name was conditionally acceptable but its resubmission is contingent upon addressing all other deficiencies.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

BLA

Impact

Impact score

0.75

Estimated delay

270 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The Complete Response Letter highlights significant deficiencies in the proposed labeling (prescribing information, carton, and container) and mandates a comprehensive safety update. The proprietary name approval is conditional upon resolving these core issues, indicating that the application is not yet ready for approval.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 25%