Review of the minutes of subject expert committee meetings of biologics and biosimilars division held in 2022–2023 in India

Abstract Background: Biologics play a pivotal role in the treatment of cancer, autoimmune disorders, and other rare diseases. In view of the high demand for affordable alternatives, the use of biosimilars has significantly increased in India. The need was felt to review the regulatory landscape of biologics and biosimilars in India. Objective: The objective of the study is to review and analyze outcomes of the review process of subject expert committee (SEC) meetings pertaining to approvals of biologics and biosimilars. Materials and Methods: A retrospective, descriptive study was conducted using publicly available minutes of SEC-Biologics division meetings (January 2022–December 2023). Data on the type of agenda items, type of sponsors, therapeutic areas, decisions (approval, recommendation, or rejection), and clinical trial (CT) waivers were extracted and analyzed. Chi-square test and odds ratios were used to determine associations. Results: A total of 137 s meetings discussed 388 items, of which 258 were related to CT and marketing applications. Biosimilars (53.9%) outnumbered biologics (46.1%). CTs made up 49.6% of agenda items, with oncology and COVID-19 as leading therapy areas. Submissions from Indian pharma sponsors were more compared to multinational companies. Overall, 65% of applications were approved, and 60% of CT waiver requests were granted. Reasons for rejections or recommendations included inadequate safety, immunogenicity, or efficacy data, particularly in the local population. Conclusion: The regulatory review process for biologics and biosimilars appears to be timely and consistent. A higher number of CT and trial waivers indicate a patient-centric facilitatory approach without compromising safety, as there is emphasis on submission of local CT data.