Biosimilars – Corporate Strategies – Biosimilar Developer Strategies
Biosimilar sponsors are not required to replicate all reference product clinical trials for the approval of their biosimilars via regulatory agencies’ abbreviated pathways. However, they need to consider which population of patients to select (or whether to include only healthy volunteers, if appropriate) for pivotal studies. To satisfy regulators, trials must be conducted in the most-sensitive population, although physicians may prefer to see clinical data in the indication for which they will be prescribing the biosimilar, an issue further complicated by the fact that biologics may be licensed for multiple indications across therapy areas. Biosimilar sponsors must consider the potential difficulty recruiting particular patient populations when designing their clinical trial program; for example, oncologists may be more inclined to recommend that patients enroll in trials of novel therapies.
Yashu Malhotra, M.Pharm., is an analyst on the Biosimilars and Oncology teams at Clarivate. Previously, she was a senior analyst in the life sciences department at Course5 Intelligence. She also worked in competitive intelligence at WNS Global Services. Ms. Malhotra earned her master’s degree in pharmacy (quality assurance) from India’s Delhi Institute of Pharmaceutical Sciences and Research.