Biosimilars and Biologics

Biography

Kurt R Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity. As the Co-Founder and Primary Author of Hyman, Phelps & McNamara’s FDA law blog, he often leads the response to new rules and regulations, sharing his interpretation with the broader legal community. He has co-authored and contributed to several text books, including “Generic and Innovator Drugs: A Guide to FDA Approval Requirement’s”; “Pharmaceutical, Biotechnology, and Chemical Inventions”; “Fundamentals of US Regulatory Affairs” and “FDLI’s Drug and Biologic Approvals: The Complete Guide for Small Businesses-FDA Financial Assistance and Incentives”.

Research Interest

Biosimilars & Pharmacies