Sandoz Inc.EG12014

BLA 761271 COMPLETE RESPONSE

Sandoz Inc.

Attention: Raheel Khan, MBA, RAC Associate Director

100 College Road West

Princeton, NJ 08540

Dear Raheel Khan,

Please refer to your biologics license application om

for EG12014.

We acknowledge receipt of your amendment dated om

complete response to our oe , action letter.

, which constituted a

We have completed our review of this application and have determined that we cannot approve this application in its present form. We have described our reasons for this action below and, where possible, our recommendations to address these issues.

PRODUCT QUALITY

CMC Microbiology:

() 4)

FACILITY INSPECTIONS Following a CGMP inspection and pre-license inspection (PLI) of

drug product manufacturing facility listed in this submission, the FDA conveyed deficiencies to the representative of the facility. The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response to your application. Our determination that the facility's responses are satisfactory will depend on a finding that the facility has come into compliance with CGMP and has addressed any deficiencies

Reference ID: 5490589

BLA 761271 Page 2

specific to your application. You should coordinate with the facility for timely resolution of all inspection deficiencies, as well as to determine if any deficiencies may require updates to your application. Your complete response should include the date(s) of the facility's response(s) to the FDA Form 483. Please refer to Compliance Program CP 7356.002 for guidance on post-inspection activities specific to CGMP compliance evaluation. The FDA may determine that a CGMP reinspection and/or additional PLI is needed to confirm satisfactory resolution of inspection deficiencies before this application can be approved. If both CGMP and PLI reinspection are needed, the PLI coverage will generally occur following a determination that the facility is in compliance with CGMP.

PRESCRIBING INFORMATION

We reserve comment on the proposed labeling until the application is otherwise adequate. We encourage you to review the labeling review resources on the Prescription Drug Labeling Resources’ and Pregnancy and Lactation Labeling Final Rule? websites, including regulations and related guidance documents and the Selected Requirements for Prescribing Information (SRPI) - a checklist of important format items from labeling regulations and guidances. In addition, we encourage you to review the FDA guidance for industry Labeling for Biosimilar Products.

CARTON AND CONTAINER LABELING

We reserve comment on the proposed labeling until the application is otherwise adequate.

PROPRIETARY NAME Please refer to correspondence dated, om , which addresses the proposed proprietary name, . This name was found conditionally acceptable pending approval of the application in the current review cycle. Please resubmit the proposed proprietary name when you respond to all the application deficiencies that have been identified in this letter.

SAFETY UPDATE When you respond to the above deficiencies, include a safety update. The safety update should include data from all nonclinical and clinical studies of the product under

consideration regardless of indication, dosage form, or dose level.

(1) Describe in detail any significant changes or findings in the safety profile and their relevance, if any, to whether there may be clinically meaningful differences

https://www.fda.gov/drugs/laws-acts-and-rules/prescription-drug-labeling-resources

2 https://www.fda.gov/drugs/labeling-information-drug-products/pregnancy-and-lactation-labeling-drugs- final-rule

U.S. Food and Drug Administration

Silver Spring, MD 20993

www.fda.gov

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BLA 761271 Page 3

between the proposed biosimilar product and the U.S.-licensed reference product.

(2) When assembling the sections describing discontinuations due to adverse events, serious adverse events, and common adverse events, incorporate new safety data as follows:

e Present new safety data from the clinical studies for the proposed indication using the same format as the original BLA submission.

e Present tabulations of the new safety data combined with the original BLA data.

e Include tables that compare frequencies of adverse events in the original BLA with the retabulated frequencies described in the bullet above.

(3) Present a retabulation of the reasons for premature study discontinuation by incorporating the drop-outs from the newly completed studies. Describe any new trends or patterns identified.

(4) Provide case report forms and narrative summaries for each subject who died during a clinical study or who did not complete a study because of an adverse event. In addition, provide narrative summaries for serious adverse events.

(5) Describe any information that suggests a substantial change in the incidence of common, but less serious, adverse events between the new data and the original BLA data.

(6) Provide updated exposure information for the clinical studies (e.g., number of subjects, person time).

(7) Provide a summary of worldwide experience on the safety of this product, including adverse events known to be associated with the use of the product and immunogenicity. Include an updated estimate of use for this product marketed in other countries.

(8) Provide English translations of current approved foreign labeling not previously submitted.

OTHER

Within one year after the date of this letter, you are required to resubmit or take other actions available under 21 CFR 601.3(b)). 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). You may also request an extension of time in which to resubmit the application.

U.S. Food and Drug Administration Silver Spring, MD 20993 www.fda.gov

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A resubmission must fully address all the deficiencies listed in this letter and should be clearly marked with "RESUBMISSION" in large font, bolded type at the beginning of the cover letter of the submission. The cover letter should clearly state that you consider this resubmission a complete response to the deficiencies outlined in this letter. A partial response to this letter will not be processed as a resubmission and will not start a new review cycle.

You may request a meeting or teleconference with us to discuss what steps you need to take before the application may be approved. If you wish to have such a meeting, submit your meeting request as described in the draft guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of BSUFA Products.

The product may not be legally marketed until you have been notified in writing that this application is approved.

If you have any questions, contact ow

Sincerely,

{See appended electronic signature page} (b) (4)

U.S. Food and Drug Administration Silver Spring, MD 20993 www.fda.gov

Reference ID: 5490589

Signature Page 1 of 1

This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.

(b) (4)

12/05/2024 01:33:11 PM signing on behalf of Good

Reference ID: 5490589