On May 6, the Central Drug Standard Control Organization published the draft version of the Revised Guidelines on Similar Biologics, inviting comments from the concerned stakeholders. These guidelines were prepared after a Committee composed of technical subject experts, representatives from the National Institute of Biologics, Dept. of Biotechnology, and representatives from industries manufacturing similar biologics. As explained in the introductory pages, the guidelines are revised in light of advances in scientific knowledge and to update the existing guidelines in light of the international ones like WHO TRS 1043: Guidelines for evaluation of biosimilars. If approved, the draft guidelines will replace the present Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India, 2016 (discussed in detail by Late Christopher Ohly here).
The salient features of the draft guidelines, as stated in the preface are :-
a. Introduction of scientific considerations and key principles for licensing of similar biologics.
b. Sections of 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.
Stakeholders can send in their comments in 30 days (by June 5) to [email protected]. We encourage the readers to take a look at the draft guidelines here and share their views!