Current Challenges in Developing Biosimilars and Biologics

Description :

The regulatory process for biologic agents, with approval depending most heavily on demonstration of safety and efficacy in clinical trials, regulatory review of biosimilars focuses on molecular characterization and preclinical studies and pharmacokinetic and pharmacodynamic studies to establish biosimilarity, with additional studies assessing immunogenicity and other potential toxicities; clinical trials are performed if uncertainty remains regarding safety and efficacy of the biosimilar. As noted by the authors, often 50% or more of the data in applications for approval of biosimilar agents concern manufacturing processes. Further, the regulatory approval process for biosimilars does not require the performance of clinical trials across all approved indications of the reference drug; with approval, a biosimilar drug may have labeling that is identical to that of the reference product across multiple indications. Thus, as noted by the authors, clinician appraisal of and confidence in biosimilars will initially depend less on large clinical trials than on preclinical and pharmacologic data establishing bioequivalence and on their own clinical experience. In the absence of data from large clinical trial programs, there is also uncertainty regarding how biosimilars can be integrated into evidence-based clinical practice guidelines