Samsung Bioepis Co., Ltd.: Pyzchiva

The effective action date will remain June 28, 2024, the date of the original letter.

BLA 761425 seeks licensure of Pyzchiva (ustekinumab-ttwe) injection 130 mg/26 mL single-dose vial for intravenous use as interchangeable with Stelara (ustekinumab) injection 130 mg/26 mL single-dose vial for intravenous use.

For administrative purposes, we have split BLAs 761373 and 761425 as follows:

761425/Original 2. A separate correspondence was issued for BLA 761373/Original 1 and BLA 761425/Original 1.

If you believe that there are grounds for issuing the approval letter before the expiration of the exclusivity period, you should amend your application accordingly.

Refer to the BLA Approval letter for BLA 761373/Original 1 and BLA 761425/Original 1 for required pediatric assessments.

We remind you of your BLA 761425 postmarketing commitment:

All submissions, including supplements, relating to these postmarketing commitments should be prominently labeled "Postmarketing Commitment Protocol,"

Therefore, there is a lack of assurance that the commercial materials are not going to drift from SB4 clinical materials and the materials used to establish the analytical similarity.

To ensure product quality and cell culture process consistency, implement the following controls and update all the appropriate sections of the BLA with this information:

Agency on February 8, 2018, is not adequate to support that the currently proposed drug product filling control strategy provides sufficient assurance that each pre-filled syringe (PFS) is filled with sufficient SB4 product to meet the current US label claim of 50 mg/mL and 25 mg/0.5mL for Enbrel.

For example, drug substance lot 15-602E-002 had a protein concentration of a) at release and the resulting drug product lot, 00003, had a protein concentration o: Because the drug product is OM itis unclear why there is such variability between the drug substance protein concentration and the subsequent drug product protein concentration.

Provide shipping validation data for the drug product from real-time shipping studies or from studies that are sufficiently representative of the commercial shipping conditions.

Provide sterilization validation for the minimum ™® in the BLA resubmission.

January 29, 2018 (IR #1 and #2) regarding the revision of acceptance criteria for release and stability was not adequate.

In addition, include a clear definition of what constitutes as test sample data comparable to reference standard (with respect to number of peaks, rank order of peak area, relative retention time, etc.) for all chromatography methods in the resubmission.

Provide all available product quality data to support the compatibility of the SB4 drug product with expected levels of in the intended pre-filled syringe at long-term conditions up to the proposed expiry period of {months in the resubmission.

If you do not take one of these actions, we may consider your lack of response a request to withdraw the application under 21 CFR 601.3(c).