The Central Drugs Standard Control Organization (CDSCO) has released draft guidelines on “Similar Biologics – Regulatory requirements for Marketing Authorization in India, 2025” and is inviting comments from all concerned stakeholders. This notice was issued on May 6, 2025.
This revision of the existing guidelines, initially published in 2012 and updated in 2016, comes in light of advancements in scientific knowledge and international regulatory practices. A dedicated committee comprising technical experts from various organizations, including the National Institute of Biologicals (NIB), the Department of Biotechnology (DBT), and representatives from industries involved in manufacturing similar biologics, was constituted to formulate these revisions.
The draft guidelines aim to provide a clear regulatory pathway for manufacturers seeking marketing authorization for similar biologics in India. According to the CDSCO, these guidelines emphasize a comprehensive stepwise approach to demonstrate similarity between a proposed similar biologic product and its reference biological product (RBP).
Key Highlights of the Draft Guidelines
The revised guidelines place a strong emphasis on robust orthogonal analytical tools and in vitro studies to establish similarity in structural and functional aspects between the similar biologic and the RBP. This aligns with the global trend towards potentially reducing the reliance on extensive non-clinical studies.
The document incorporates updated scientific considerations and key principles for the licensing of similar biologics, aiming for greater clarity and flexibility in the regulatory process while maintaining stringent standards.
The guidelines provide detailed information on the use of international and in-house reference standards for ensuring the quality and consistency of similar biologics.
The draft offers new guidance on determining the necessity for in vivo animal studies, emphasizing the implementation of the 3Rs principles (Replace, Reduce, Refine) to minimize animal use in testing.
The revised guidelines introduce statistical intervals for establishing similarity ranges and provide clarity on statistical considerations for sample size calculation in clinical studies.
The document outlines the updated pathway for the approval of similar biologics in India, providing a clearer roadmap for manufacturers.
The CDSCO has urged all interested stakeholders to carefully review the draft guidelines and provide their comments and suggestions in the specified format as a Word document to biological@cdsco.nic.in within 30 days of the guidelines being published on the website.
These draft guidelines reflects the growing importance of similar biologics in providing cost-effective treatment options while ensuring the same standards of quality, safety, and efficacy as their reference products.
