By Ajay Babu Pazhayattil, Avinash Joshi, Sanjay Sharma
Generic and biosimilar drugs have already achieved $408 billion in savings for America's patients and healthcare system. Over the past decade, these drugs have collectively saved the U.S. healthcare system $2.9 trillion, with annual savings continuing to rise. Generics account for 90% of prescriptions filled in the U.S., yet they only constitute 17.5% of drug spending and represent a mere 1.5% of total U.S. healthcare expenditure [1]. This trend underscores the need for a steadfast commitment to maintaining stringent development and commercialization compliance for generic and biosimilar products at their development and manufacturing centers. Notably, Indian developers play a significant role in this, as 47% of generics for the U.S. market are sourced from India [2], with a steady increase in ANDA filings from Indian developers. This article elucidates a business value enhancement proposition when developing and commercializing generic drug products.