IntroductionIndia’s regulatory landscape for biologic and biosimilar medicines continues to evolve.In response to scientific advances and accumulated regulatory experience, the CentralDrugs Standard Control Organization (CDSCO) and the Department of Biotechnology(DBT) have jointly released the Draft Guidelines on Similar Biologics – RegulatoryRequirements for Marketing Authorization in India, 2025. These proposed guidelinesrevise the earlier 2016 version, building […]