Sandoz Inc.: EG12014

FDA office indicated on the FDA 483 prior to your complete response to your application.

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.

1. You have not demonstrated PK similarity between LA-EP2006 and US-licensed Neulasta.

This bridge is needed to justify the relevance of data from your clinical studies comparing EU-approved Neulasta to LA-EP2006 to support a demonstration of biosimilarity of LA-EP2006 to US-licensed Neulasta.

In the absence of an adequate scientific bridge, there is insufficient data to support a demonstration of no clinically meaningful differences between LA-EP2006 and US-licensed Neulasta.

3. Once the root causes that may have led to the inability to demonstrate PK similarity are identified, you should conduct a feasibility assessment to determine whether developing your product as a proposed biosimilar product under section 351(k) of the PHS Act is still a viable option for licensure of LA-EP2006.

2015. We reserve comments on the proposed container label and carton labeling until the application is otherwise adequate.

3. Include storage under accelerated conditions as part of the annual stability program in your post-approval drug substance and drug product stability commitments.

The proposed presentation(s) may need Human Factors studies to demonstrate that users can accurately measure the doses.

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).