Ajmal Aboobacker Kumangal
Ajmal Aboobacker Kumangal, M Pharm, Pharmaceutical Regulatory Affairs at Acharya & BM Reddy College of Pharmacy, India
JournalThe end of the two-tier system: A comparative review of the FDA’s 2024/2025 shift on biosimilar interchangeability and its impact on global harmonisation
This article analyses the FDA draft guidance changes for 2024 and 2025 and assesses how these modifications may affect market competition and international regulatory harmonisation