Biosimilar Biologic Drugs: A Systematic Approach To Development, Manufacturing And Clinical Applications - IVT BLOG

摘要

INTRODUCTION The rising cost of biologic medicines has necessitated the development of biosimilar drugs. The US Drug Price Competition and Patent Term Restoration Act of 1984, widely known as the Hatch-Waxman Act, introduced biosimilar drugs legislation to establish a regulatory pathway for pharmaceutical companies to develop identical and more cost-effective copies of drugs that were facing patent expiration. These research and development (R &.