Regulatory imperatives in chemistry, manufacturing, and control for biosimilars a comprehensive analysis

By Rajendra Kunda, Rick Best, Steve LoCastro and Hao Liu2024-03-06T15:00:00

The Asia-Pacific (APAC) region has emerged as a dynamic centre for the development and approval of biosimilars, revealing a complex regulatory landscape that requires meticulous attention to chemistry, manufacturing, and controls (CMC) factors. This article explores the essential regulatory aspects inherent to CMC for biosimilar assessment and approval by agencies across APAC countries. It also focuses on biosimilar guidance from regulatory agencies and how this can be interpreted by sponsors when performing clinical trials and registration of biosimilars.

How to read this journal article

Thank you for visiting Regulatory Rapporteur. Journal articles are restricted to registered users and TOPRA members.

Already a member or have an account? Sign in.

1. REGISTER FOR FREE

Free access to selected content

Register now to continue to access industry news, editorials and podcasts plus one member-only journal article each month.

Create your own library to save your favourite content.

Create a free account

2. Members login

Already a TOPRA member?

Log-in now using your MyTOPRA credentials, for unlimited access to all Regulatory Rapporteur journal articles, the online archive and latest industry news and podcasts.

3. JOIN TOPRA

Special offer on
TOPRA membership

Join TOPRA today and get membership until the end of 2025 for the exclusive rate of £290.

In addition to unlimited access to Regulatory Rapporteur content, as a TOPRA member you will also be able to enjoy a wide range of benefits including career boosting resources, savings on our events and training, and access to our regional networks and special interest groups.

This offer ends 31 July 2024

Become a member