CDSCO Issues Draft Guidelines for Biosimilars for Marketing Authorization, Inviting comment From Stakeholders

New Delhi: Through a recent notice, the Central Drugs Standard Control Organisation (CDSCO), the Directorate General of Health Services, Government of India, has released a draft of the revised Guidelines on Similar Biologics (Biosimilars) regulatory requirements for marketing authorization in India, 2025, for public consultation and sought feedback from stakeholders with an aim to update the current guidelines to reflect recent international guidelines.

This occurred in light of the expansion of scientific understanding and expertise. A committee made up of technical subject matter experts, representatives from the National Institute of Biologicals (NIB) and Department of Biotechnology (DBT), and industries that manufacture similar biologics was established to help with the process of updating the current guidelines in accordance with the latest international guidelines.

The Guidelines on Similar Biologic-Regulatory Requirements for Marketing Authorization in India was published in the year 2012 by CDSCO in collaboration with the Department of Biotechnology (DBT) to address the regulatory pathway for similar biologics in India. The guidelines were then revised in the year 2016 with more focus on scientific principles and a stepwise approach to be applied during the demonstration of similarity between a similar biological product and its reference biological product.

As per NDCT Rules 2019, “Similar Biologic” means a biological product which is similar in terms of quality, safety and efficacy to a reference biological product (RBP) licensed or approved in India or any innovator product approved in International Council of Harmonisation (ICH) member countries. The term “similar biologic” is being widely used by many drug regulatory agencies, such as the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), the WHO, etc. Both the terms “similar biologics” and “biosimilar” essentially refer to the same terminology and can be used interchangeably.

In view of committee recommendations, the present Guideline document, 2025, was framed, which represents the outcome of the revision process and replaces GUIDELINES ON SIMILAR BIOLOGICS: Regulatory Requirements for Marketing Authorization in India, 2016.

This guideline considers the current scientific evidence and scientific updates from the international guidelines, majorly WHO TRS 1043: Guidelines for Evaluation of Biosimilars. Since major countries are moving for a waiver of non-clinical studies for similar biologics, the current revision principally focuses on strengthened orthogonal analytical tools and in vitro studies to establish similarity between the similar biologic product and the reference biological product.

The salient features of the revision include

a. Introduction of scientific considerations and key principles for licensing of similar biologics.

b. Sections on quality and nonclinical and clinical evaluation are updated to make them more consistent with current international practices and to provide more clarity and flexibility.

c. Revised pathway for approval of similar biologics in India

d. Specific topics addressed in the revision include but are not limited to:

• Next generation analytical methodologies introduced for establishing analytical similarity

• Use of reference standards and development of in-house reference standards elaborated

• Elaborative list of in vitro studies included

• New guidance on determining the need for in vivo animal studies and on the implementation of the 3Rs principles (“Replace, Reduce, Refine”) to minimize the use of animals in testing

• Statistical intervals for establishment of similarity ranges to provide clarity and focus on statistical consideration in calculation of sample size for clinical studies.

The notice added that "The Draft Guidelines is now being placed in the public domain for inviting comments/suggestions from concerned stakeholders. This window of opportunity will close within 30 days of publishing the draft guidelines on the CDSCO website, and, once finalized, there will be minimal scope for change in this document."

Additionally, the committee stated that all interested stakeholders are requested to submit their comments and suggestions within 30 days to biological@cdsco.nic.in, using the prescribed format provided in the annex.

"The suggestions/comments received on the above email address within the 30 days shall be taken into consideration for finalization of the draft guidance document," the notice further added.

To view the full draft notice, click the below link:

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