FDA EPYSQLI BLA 761340 Regulatory Review & REMS Collection — Samsung Bioepis

This FOIAdocs regulatory document collection brings together FDA review records and regulatory correspondence for EPYSQLI (eculizumab-aagh), BLA 761340, submitted by Samsung Bioepis. The collection contains four substantive FDA records totaling 25 pages and follows the application from the October 2023 mid-cycle review through detailed REMS discussions in March 2024.

The records provide a chronological view of FDA's review, including scientific and CMC information requests, comparative analytical assessment, REMS and ETASU requirements, labeling negotiations, postmarketing requirements and commitments, facility inspections, and detailed FDA feedback on REMS implementation.

What's included

• October 16, 2023 Mid-Cycle Communication
• December 2023 REMS Information Request and FDA/applicant correspondence
• January 9, 2024 Late-Cycle Meeting Minutes
• March 28, 2024 detailed FDA REMS comments
• FDA information requests addressing statistics and comparative analytical/CMC issues
• REMS requirements, including ETASU A, B, and D
• FDA discussions of labeling, postmarketing requirements and commitments, and facility inspections
• Detailed REMS feedback covering enrollment, distribution and dispense authorization, REMS operations, website materials, key performance indicators, and assessment requirements
• FOIA release documentation for the individual records

The October 2023 mid-cycle record includes detailed FDA questions concerning the comparative analytical assessment of SB12 and reference eculizumab products, including analytical methods, reference lots, quality attributes, and scientific justification. Portions of this record were withheld by FDA under FOIA exemption (b)(4).

The subsequent records show the progression of FDA's REMS review. In December, FDA instructed Samsung to incorporate additional elements to assure safe use and requested information about product distribution and authorization-to-dispense processes. By the January late-cycle meeting, FDA stated that a REMS was necessary and documented ongoing labeling negotiations, anticipated postmarketing requirements and commitments, and facility inspection status.

Package format: Organized ZIP collection containing the four substantive FDA regulatory records as individual PDFs, plus FOIA release documentation.

Application: BLA 761340
Product: EPYSQLI (eculizumab-aagh) / SB12
Applicant: Samsung Bioepis Co., Ltd.
Documents: 4 substantive FDA regulatory records
Pages: 25 substantive pages
Coverage: October 2023 – March 2024