India’s biosimilar reform and the global shift away from redundant clinical trials

Abstract India’s 2025 draft guidelines on biosimilars mark an important change in how these medicines are regulated. The new approach focuses more on laboratory data, such as analytical and pharmacokinetic results, and less on large clinical trials. This is in line with current global thinking from agencies such as the European Medicines Agency and the World Health Organization. The commentary explains what the new guidelines mean, how they compare with past rules, and what challenges may arise during implementation. It also highlights India’s chance to become a leader in global biosimilar access, especially for low- and middle-income countries. For this reform to succeed, strong systems, clear guidance, and proper training will be essential.