Certara Investor Day Presentation Deck

Regulatory priority to increase access to generics Simcyp Simulator can advance development of complex generics Increasing Access to Generic Alternatives for Complex Drugs Importance to FDA FDA supports the development of generic versions of complex drug products because they represent nearly one-third of drug products currently used but have less generic competition than non-complex drugs. The presence of generic drugs on the market helps to ensure availability of quality medicines at a lower cost to the American public. Zhao, Generic Drug Research Public Workshop May 2017, MD, USA General PBPK Model Applications for Generic Products PPI - DDI Gl local concentration Dissolution Waiver of in vivo studies BE 2021 Advancing Regulatory Science at FDA Specific populations Locally acting product assessment Critical quality attribute In vivo alcohol dose dumping simulation Mechanism change risks Increasing trends in using PBPK models to support regulatory decision making in the realm of generic drug development FDA Milestone FDA Approval of Diclofenac Gel First complex generic approved using the Simcyp Simulator to establish virtual bioequivalence in lieu of a clinical trial, saving significant time and money. 7amneal 10000162-833- air Research Highlight THEO COMPAR Diclofenac Sodium Topical Gel, 1% Use the Dosing Card Attached Inside the Carton See Medication Guide and Patient Instructions Inside of Carton For Topical Use Only Rx only Diclofenac Sodium Topical Gel, 1% Use the Dosing Card Attached Inside the Carton See Medication Guide and Patient Instructions Inside of Carton For Topical Use Only Reply Net Wt 100 g Net Wt 100 g FDA Physiologically-based pharmacokinetic modeling supported approval of a locally acting drug based on an efficient alternative bioequivalence approach. 40 CERTARA

View entire presentation