Approval Letter Other (Nov 13, 2025)

Summary

The FDA has issued a provisional determination for BLA 761338/Original 2 for Steqeyma (ustekinumab-stba) injection, finding it meets the interchangeability criteria with Stelara (ustekinumab). However, approval cannot be granted at this time due to unexpired exclusivity for the first interchangeable biosimilar biological products. The letter outlines deficiencies related to labeling, safety updates, and product quality (stability and compatibility studies), and provides instructions for resubmission to obtain eventual approval.

Key points

• All future submissions to BLA 761338/Original 2 must specify the BLA number and the Original number to which each submission pertains.
• Submit an amendment no more than six months prior to the date the application will be eligible for approval, clearly identified as 'REQUEST FOR APPROVAL' in the cover letter.
• The amendment must provide the legal/regulatory basis for the request for approval and include a copy of any relevant supporting documentation.
• The amendment should include a safety update and identify any changes in the application (updated labeling; chemistry, manufacturing, and controls data; and risk evaluation and mitigation strategy (REMS)), or clearly state if there are no changes.
• Review the FDA guidance for industry 'Labeling for Biosimilar Products'.
• Resubmit the proposed proprietary name (Steqeyma) when all application deficiencies have been identified in this letter are addressed.
• Include a safety update with data from all nonclinical and clinical studies, detailing any significant changes or findings in the safety profile and their relevance to clinically meaningful differences between the proposed biosimilar product and the US-licensed reference product.
• Present new safety data from clinical studies for the proposed indication using the same format as the original BLA submission.

Cited reasons

• Proprietary Name Resubmission
• Comprehensive Safety Update Required
• Drug Product In-Use Stability Data Deficiency
• Drug Product Compatibility Studies Recommended
• Incomplete/Inaccurate Quality Information Responses
• The application for Steqeyma (ustekinumab-stba) as an interchangeable biosimilar to Stelara provisionally met interchangeability criteria but cannot be approved due to unexpired first interchangeable exclusivity. Additionally, the application has deficiencies related to proprietary name resubmission, a required comprehensive safety update, specific drug product stability and compatibility data, and administrative issues with quality information responses.

Recommended actions

• All future submissions to BLA 761338/Original 2 must specify the BLA number and the Original number to which each submission pertains.
• Submit an amendment no more than six months prior to the date the application will be eligible for approval, clearly identified as 'REQUEST FOR APPROVAL' in the cover letter.
• The amendment must provide the legal/regulatory basis for the request for approval and include a copy of any relevant supporting documentation.
• The amendment should include a safety update and identify any changes in the application (updated labeling; chemistry, manufacturing, and controls data; and risk evaluation and mitigation strategy (REMS)), or clearly state if there are no changes.
• Review the FDA guidance for industry 'Labeling for Biosimilar Products'.
• Resubmit the proposed proprietary name (Steqeyma) when all application deficiencies have been identified in this letter are addressed.
• Include a safety update with data from all nonclinical and clinical studies, detailing any significant changes or findings in the safety profile and their relevance to clinically meaningful differences between the proposed biosimilar product and the US-licensed reference product.
• Present new safety data from clinical studies for the proposed indication using the same format as the original BLA submission.

Deficiency summary

The application for Steqeyma (ustekinumab-stba) as an interchangeable biosimilar to Stelara provisionally met interchangeability criteria but cannot be approved due to unexpired first interchangeable exclusivity. Additionally, the application has deficiencies related to proprietary name resubmission, a required comprehensive safety update, specific drug product stability and compatibility data, and administrative issues with quality information responses.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

BLA 351(k) Biosimilar

Impact

Impact score

0.75

Estimated delay

365 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The application for Steqeyma (ustekinumab-stba) as an interchangeable biosimilar to Stelara provisionally met interchangeability criteria but cannot be approved due to unexpired exclusivity. Key deficiencies include proprietary name resubmission, a required comprehensive safety update, specific drug product stability and compatibility data, and administrative issues with quality information responses.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 25%