摘要：Biosimilars are highly similar versions of already authorized innovator biological therapies.They demonstrate no clinically meaningful difference with their innovator products in terms of efficacy,safety and quality characteristics and biological activity.Biosimilars have demonstrated growing acceptance and use,especially in the developing countries due to severe cost constraints.Global market for Indian non-innovator products is approximately worth USD 1.5 Billion/annum with an anual growth rate of 27%.Estimated exports of Indian biopharmaceutical products have been increasing at a rate of 47%.In India,there is a good acceptance of non-innovator healthcare products amongst healthcare professionals and patients.Several home grown biopharmaceutical industries are now actively developing and marketing non innovator products in India.
关键词：Biological Response Modifiers (BRM);Similar Biologic Product (SBA);Follow On Biologic (FOB);Intrnational Non-proprietary Name (INN)
