Charu Manaktala
Senior Medical Director Quintiles IMS, India
Title: Clinical development of biosimilars for Western markets: Planning for success
Biography
Biography: Charu Manaktala
Abstract
Clinical development of biosimilars is an expensive and time consuming undertaking. The biosimilars space continues to evolve rapidly and presents a number of unique challenges and fierce competition. There are as many as 20 biosimilars in development for some of the top-selling biologicals creating an intense race for the sponsors, especially those wishing to enter the western markets. To avoid any delays, biotech companies need solid clinical development plans built on the latest regulatory guidance with intimate knowledge of the clinical trial landscape. This presentation will discuss how companies could design their clinical development plans to meet the western regulators expectations. It will share insights on determining the extent of clinical data requirements, design of clinical studies, considerations on the study population/indication, endpoints, evaluation of risk of immunogenicity and designing global development programs. Further, the presentation will share insights on efficient operational delivery of the safety and efficacy studies and outline best practices for accessing and retaining patients in biosimilars clinical studies.