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

ASIA-Skyline-illo

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 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.

Login

3. JOIN TOPRA

TOPRA membership

Become a TOPRA member and join our global regulatory affairs community.

  • Great savings on our events and training.
  • Be part of our dynamic international community.
  • Contribute to the profession.
  • Grow your skills and knowledge.
  • Take your career to the next level.
Become a member