A New Era for Biosimilars: Powered by Analytics
In a historic regulatory shift, the U.S. FDA has reportedly accepted the first application for a biosimilar monoclonal antibody without requiring a comparative clinical efficacy study.
This landmark decision signals the beginning of a new era in biosimilar development, where scientific rigor and affordability converge. It also aligns the FDA with the European Medicines Agency (EMA) and the UK’s MHRA, which have already embraced streamlined, evidence-based pathways for biosimilar approval.
At Biofidus, we see this as a transformative opportunity for the biopharmaceutical industry. With clinical efficacy studies no longer a default requirement, the burden of proof lies largely with analytical comparability, the domain where Biofidus excels. Our advanced analytical platforms and deep expertise in structural and functional characterization of protein-based therapeutics position us as your ideal partner in biosimilar development.
There is scientific consensus that a robust data package, consisting of analytical comparability studies and an appropriately designed pharmacokinetic (PK) study, will in most cases provide sufficient evidence of biosimilarity. Comparative efficacy trials have repeatedly failed to provide meaningful additional information, while analytical methods have proven to be more sensitive and predictive. A recent case study on ustekinumab biosimilars confirmed that single-dose pharmacokinetic studies and analytical data alone are sufficient to draw conclusions about comparable immunogenicity.
The above underscores the central role of analytical comparability in modern biosimilar development and empowers developers to focus resources on robust analytical packages, accelerating timelines and reducing costs by up to 90%
Biofidus supports this evolution with tailored comparability studies that meet the highest regulatory standards. From glycan profiling and charge variant analysis to potency assays as well as surface plasmon resonance, our services are designed to uncover the critical quality attributes that define biosimilarity. We help you build the totality of evidence regulators now prioritize.
As the biosimilar landscape opens to mid-sized and generic companies, Biofidus stands ready to guide your journey. Let’s redefine biologics together—through science, speed, and smarter development.
Interested in our biosimilar services?
https://www.biofidus.de/studies/biosimilar-studies/
References and additional resources:
“Professor Sarfaraz K. Niazi Secures First-Ever FDA Acceptance to Waive Clinical Efficacy Studies for Monoclonal Antibody Biosimilars” PR Newswire, https://www.prnewswire.com/news-releases/professor-sarfaraz-k-niazi-secures-first-ever-fda-acceptance-to-waive-clinical-efficacy-studies-for-monoclonal-antibody-biosimilars-302542781.html. Accessed 5 Sept. 2025
Guillen E, Barry S, Jost N, Ekman N, Knippel V, Kuhlmann-Gottke J, Maier J, Weise M, Laslop A, Anour R, van Zandbergen G, Kirsch-Stefan N. The Tailored Biosimilar Approach: Expectations and Requirements. Drugs. 2025 May;85(5):601-608. doi: 10.1007/s40265-025-02168-y. Epub 2025 Apr 1. PMID: 40169518; PMCID: PMC12031863.
Niazi S. Scientific Rationale for Waiving Clinical Efficacy Testing of Biosimilars. Drug Des Devel Ther. 2022 Aug 24;16:2803-2815. doi: 10.2147/DDDT.S378813. PMID: 36043044; PMCID: PMC9420434.
Schiestl M, Roy N, Trieb M, Park JP, Guillen E, Woollett G, Wolff-Holz E. Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study. BioDrugs. 2025 Sep;39(5):769-776. doi: 10.1007/s40259-025-00733-1. Epub 2025 Jul 17. PMID: 40676496; PMCID: PMC12354544.3