Complete Response Letter BLA 761271 (Dec 5, 2024)

Summary

This document is a deficiency letter from the FDA regarding Biologics License Application (BLA) 761271. It outlines several deficiencies and required actions related to facility inspection, labeling, proprietary name, and a comprehensive safety update, which must be addressed for the application to be approved.

Key points

• Coordinate with the facility for timely resolution of all inspection deficiencies.
• Include the date(s) of the facility’s response(s) to the FDA Form 483 in the complete response.
• Review labeling review resources, including regulations, guidance documents, and the Selected Requirements for Prescribing Information (SRPI) checklist.
• Review the FDA guidance for industry 'Labeling for Biosimilar Products'.
• Resubmit the proposed proprietary name when responding to all application deficiencies.
• Include a safety update when responding to the identified 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.
• Describe in detail any significant changes or findings in the safety profile and their relevance to potential clinically meaningful differences between the proposed biosimilar product and the U.S.-licensed reference product.

Cited reasons

• Resolution of Facility Inspection Deficiencies
• Inadequate Safety Update and Data Presentation
• Resubmission of Proprietary Name
• Missing English Translations of Foreign Labeling
• The FDA issued a Complete Response Letter for BLA 761271, citing significant deficiencies primarily related to the completeness and presentation of safety data, the resolution of facility inspection findings, and administrative issues concerning the proprietary name and foreign labeling translations. The agency reserves comment on proposed labeling until other deficiencies are addressed.

Recommended actions

• Coordinate with the facility for timely resolution of all inspection deficiencies.
• Include the date(s) of the facility’s response(s) to the FDA Form 483 in the complete response.
• Review labeling review resources, including regulations, guidance documents, and the Selected Requirements for Prescribing Information (SRPI) checklist.
• Review the FDA guidance for industry 'Labeling for Biosimilar Products'.
• Resubmit the proposed proprietary name when responding to all application deficiencies.
• Include a safety update when responding to the identified 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.
• Describe in detail any significant changes or findings in the safety profile and their relevance to potential clinically meaningful differences between the proposed biosimilar product and the U.S.-licensed reference product.

Deficiency summary

The FDA issued a Complete Response Letter for BLA 761271, citing significant deficiencies primarily related to the completeness and presentation of safety data, the resolution of facility inspection findings, and administrative issues concerning the proprietary name and foreign labeling translations. The agency reserves comment on proposed labeling until other deficiencies are addressed.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

BLA

Impact

Impact score

0.95

Estimated delay

365 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The primary themes of the Complete Response Letter are the need for a robust and complete safety data package, resolution of manufacturing quality issues identified during facility inspections, and administrative completeness regarding proprietary name resubmission and foreign labeling translations.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 5%