Biosimilar Development
Demonstrating clinical comparability1
A robust and complex process ensuring structural and clinical comparability is used to demonstrate a biosimilar’s clinical comparability to the reference product.
Data on pharmacokinetics, pharmacodynamics, immunogenicity, safety profile and efficacy are collected.
Replicating complex biologics
Developing biosimilars has been made possible due to modern analytical advances in characterization and development of biologics:
Accurate analytics allow assessment of critical quality attributes in the molecule that may impact clinical activity. These methods contribute to building a fingerprint of quality attributes for the reference drug.
Developing Biosimilars7
Biosimilars are assessed for similarity to the reference medicine based upon:7
- Structure
- Biological activity
- Efficacy
- Safety profile
- Immunogenicity profile
- Pharmacokinetics/Pharmacodynamics
Indications already studied in a reference product can also be approved for the biosimilar of that product through a process called “extrapolation”1,8
A biosimilar must show no clinically meaningful differences from its reference biologic in terms of safety profile, purity, and potency9
Reference medicine Biosimilar medicine
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References
- European Medicines Agency (EMA). Guideline on similar biological medicinal products. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf. Accessed: February 2024.
- Cho IH, Lee N, Song D, et al. Evaluation of the structural, physicochemical, and biological characteristics of SB4, a biosimilar of etanercept. MAbs. 2016;8(6):1136-1155.
- Brady LJ, Velayudhan J, Visone DB, et al. The criticality of high-resolution N-linked carbohydrate assays and detailed characterization of antibody effector function in the context of biosimilar development. MAbs. 2015;7(3):562-570.
- Beck A, Debaene F, Diemer H, et al. Cutting-edge mass spectrometry characterization of originator, biosimilar and biobetter antibodies. J Mass Spectrom. 2015;50(2):285-297.
- Lyubarskaya Y, Houde D, Woodard J, et al. Analysis of recombinant monoclonal antibody isoforms by electrospray ionization mass spectrometry as a strategy for streamlining characterization of recombinant monoclonal antibody charge heterogeneity. Anal Biochem. 2006;348(1):24-39.
- Berkowitz SA, Engen JR, Mazzeo JR, Jones GB. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nat Rev Drug Discov. 2012;11(7):527-540.
- Wolff-Holz E, Garcia Burgos J, Giuliani R, et al. Preparing for the incoming wave of biosimilars in oncology [published correction appears in ESMO Open. 2018 Oct 14;3(6):e000420corr1]. ESMO Open. 2018;3(6):e000420.
- FDA. Biological product definitions. 2020. https://www.fda.gov/files/drugs/published/Biological-Product-Definitions.pdf Accessed February 2024.
- Weise M, Kurki P, Wolff-Holz E, et al. Biosimilars: the science of extrapolation. Blood. 2014;124(22):3191-3196.
