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The Central Drugs Standard Control Organisation (CDSCO) has invited comments from the stakeholders on the revised guidelines on biosimilars with updated requirements for marketing authorisations in the country, in line with the latest international guidelines.
The guideline considers the current scientific evidence and scientific updates from the International Guidelines, majorly the Guidelines on Evaluation of Similar Biologics from WHO Technical Report Series, No. 1043, 2022.
Since, major countries are moving for 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 Reference Biological Product.
The revision include features such as introduction of scientific considerations and key principles for licensing of similar biologics, updation of sections of quality, non clinical and clinical evaluation to make them more consistent with current international practices and to provide more clarity and flexibility, and revised pathway for approval of biosimilars in the country.
It also addresses topics such as next generation analytical methodologies for establishing analytical similarity, elaborating use of reference standards and development of in-house reference standards, elaborating list of in vitro studies, and new guidance on determining the need for in vivo animal studies and on the implementation of the 3Rs principles (Replace, Reduce, Refine) to minimise the use of animals in testing.
It may be noted that the organisations working to prevent cruelty against animals have been demanding reduced use of animals for testing drugs, especially with the pharma industry and academia globally moving away from such tests.
The revised Guideline also looks at the topic of statistical intervals for establishment of similarity ranges to provide clarity and focus on statistical consideration in calculation of sample size for clinical studies.
The draft guidelines has been prepared by a committee comprising technical subject experts, representatives from National Institute of Biologicals (NIB), Department of Biotechnology (DBT), and representatives from industries involved in manufacturing of similar biologics.
Inviting comments from the stakeholders within 30 days, the drug regulator said, "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 CDSCO website, and, once finalised there will be minimal scope for change in this document."
The regulator observed that as patents and data protection periods for many of the biotherapeutic products expire, a new wave of products has emerged that are designed to be highly similar to the licensed originator products.
These guidelines are for the guidance of all stakeholders and are not meant to substitute or rephrase the Rules made under Drugs and Cosmetics Act, 1940 or any other relevant Acts and are subject to being in conformity with the Drugs and Cosmetics Act and Rules as may be amended from time to time.
The guidelines was first issued in 2012 to address the regulatory pathway regarding manufacturing process and quality aspects for similar biologics, and it was revised in the year 2016, with more focus on scientific principles and stepwise approach to be applied during the demonstration of similarity between a biosimilar and its reference biological product.
"It was however viewed as a 'living' document that would be further revised in line with advances in scientific knowledge and experience," said the drug regulator.
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