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.