---
title: Regulatory assessment of a generic anti-diabetic peptide drug
description: An biotech client had developed a generic version of a major anti-diabetic peptide drug and sought an assessment of its registrability.
---

[Case Studies Archive - Alacrita ](https://www.alacrita.com/case-studies)

# [Regulatory assessment of a generic anti-diabetic peptide drug](https://www.alacrita.com/case-studies/regulatory-assessment-of-a-generic-anti-diabetic-peptide-drug)

 Written by [Cort](https://www.alacrita.com/case-studies/author/cort) | Feb 8, 2022 12:33:00 PM

### Challenge:

A biotech client had developed a generic version of a major anti-diabetic peptide drug, and wanted a clearer understanding of the product's registrability, as well as support with defining the various data packages that would be required in the submission. 

### Solution:

Alacrita's regulatory team addressed the following items:

- Defined the nonclinical data package needed for registration as a biosimilar/generic in both EU and US, with high level outline design for any additional recommended studies, and identification of those nonclinical studies (in vitro/in vivo) that can be performed with API vs. those to be performed with drug product;
- Defined the clinical package needed for registration as a biosimilar in both EU and US, with high level outline design for recommended studies;
- Identified the sections of the eCTD that needed to be populated for Modules 4 and 5, and where it is acceptable to have justifications for missing data (and what those justifications would be);
- Reviewed the qualitative and quantitative composition of the client's product vs. the reference medicinal product to determine whether an abbreviated data package can be proposed;
- Assessed acceptability of current manufacturing process flow.

 

 

 

[View full post](https://www.alacrita.com/case-studies/regulatory-assessment-of-a-generic-anti-diabetic-peptide-drug)

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