Written by New Draft Guidelines on Similar Biologics 2025 – CDSCO
The CDSCO and DBT have jointly released the much-anticipated Draft Guidelines on Similar Biologics 2025. This marks a significant update over the 2016 version, incorporating global regulatory trends and streamlining the approval pathway for biosimilars in India.
Key updates include:
🔹 Enhanced focus on Quality by Design (QbD)
🔹 Revised preclinical and clinical study requirements
🔹 Stronger post-marketing surveillance framework
🔹 Greater alignment with WHO, EMA, and USFDA standards
This is a step forward in strengthening India’s position as a global hub for affordable, high-quality biologics.
The Draft Guidelines is now being placed in the public domain for inviting comments/suggestions from concerned stakeholders. All interested stakeholders are requested to provide comments/suggestions within the window of 30 days at biological@cdsco.nic.in in word document as per the format given below.
The suggestions/comments received on the above email address within the 30 days shall be taken into consideration for finalisation of the draft Guidance document.
Stakeholder’s Comments format
Name and Designation:
Firm Name:
| S.No. | Page No | Line No | Section/Sub- section/ Heading | Current text | Proposed Text | Explanation/Reference |