The Totality of Evidence Approach: How Analytics Can Cut Down Clinical Trials

The “Totality of Evidence” Approach: How Analytics Can Cut Down Clinical Trials for Biosimilars A comparative efficacy study for one biosimilar can take one to three years and cost around $24 million. FDA now says that, for many products, this study is less sensitive than the analytical data you already have. In this video, Raghuvirsinh Parmar, PhD, Director Scientific Affairs at ResolveMass Laboratories, explains the totality of evidence approach to biosimilar development. He covers why regulators are moving away from comparative efficacy studies and how a strong comparative analytical assessment can reduce the clinical work a biosimilar needs. What you will learn: ✔ How FDA's stepwise, totality-of-evidence approach to biosimilarity works ✔ What changed in 2024 (switching studies), October 2025 (FDA draft guidance on comparative efficacy studies) and 2026 (EMA reflection paper) ✔ Why analytical methods such as LC-MS/MS peptide mapping, glycan profiling and cell-based potency assays are more sensitive than clinical endpoints ✔ The three conditions in FDA's draft guidance for reducing or skipping a comparative efficacy study ✔ Which analytics carry the weight: primary structure, higher order structure, charge and size variants, and function ✔ When clinical data still matters ✔ Five steps to build an analytical package that can take the place of an efficacy trial ⏱️ Chapters 0:00 Intro 0:04 The $24M question 1:07 How the evidence bar moved 2:06 What totality of evidence means 2:59 Why the lab is more sensitive 3:58 Three conditions to skip the trial 4:57 The analytics carrying the weight 5:57 When clinical data still matters 6:56 Building a package that replaces a trial 7:57 Key takeaways 8:31 How ResolveMass can help 🔬 About ResolveMass Laboratories ResolveMass Laboratories supports small and mid-sized biotech teams with biosimilar analytical similarity programs, from reference product characterization and method development through to the comparative analytical assessment for submission. 💬 Which quality attribute worries you most in your biosimilar program? Tell us in the comments. 👍 If this helped, like the video and subscribe for more biosimilar analytics content. Disclaimer: This video is for educational purposes only and is not regulatory or legal advice. Always refer to the current FDA and EMA guidance documents for your specific product. #Biosimilars #TotalityOfEvidence #FDA #AnalyticalSimilarity #BiosimilarDevelopment #ComparativeAnalyticalAssessment #RegulatoryAffairs #Biologics #CMC #ResolveMass totality of evidence, totality of evidence approach, biosimilar development, biosimilar analytical similarity, comparative analytical assessment, comparative efficacy study, FDA biosimilar guidance 2025, FDA draft guidance comparative efficacy studies, biosimilar clinical trial, biosimilarity, EMA reflection paper biosimilars, interchangeability switching studies, peptide mapping LC-MS/MS, glycan profiling afucosylation, biosimilar CMC, ResolveMass