Approval Pathway

While small molecule development typically requires an investment of $2–3 million and takes 2–3 years, developing a biosimilar can demand $100–200 million and span 8–10 years.¹ A comparative, step-wise approach to biosimilar approval is adopted by regulatory bodies such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) to ensure that the drug maintains safety and efficacy to the reference biologic.

The proposed drug must undergo a series of testing, including non-clinical analytical, pharmacological and confirmatory clinical studies to prove biosimilarity to the reference product.² The critical and non-critical quality attributes are closely matched to the reference biologic via a series of advanced analytical techniques. Each attribute is thoroughly characterised for the originator, and the biosimilar must be reverse engineered with a high degree of molecular comparability.^2,3

THE BIOSIMILAR DEVELOPMENT AND APPROVAL PROCESS

Adapted from Rugo et al. 2016.²

COMPARISON OF DATA REQUIREMENTS FOR APPROVAL OF A BIOSIMILAR VERSUS THE REFERENCE MEDICINE4

European Medicines Agency⁴

Once approved, biosimilars can be prescribed in place of their reference products, offering patients proven treatment alternatives that could broaden access, reduce costs, and support more sustainable healthcare systems.

REFERENCES

Abbreviations: PD, pharmacodynamic; PK, pharmacokinetic.

1. GaBI Online. Comparison of the cost of development of biologicals and biosimilars. Generics and Biosimilars Initiative Journal. Published March 11, 2022. Accessed October 2025. Available at: https://gabionline.net/reports/comparison-of-the-cost-of-development-of-biologicals-and-biosimilars.
2. Rugo HS, Rifkin RM, Declerck P, Bair AH, Morgan G, Woollett G, et al. A clinician’s guide to biosimilars in oncology. Cancer Treat Rev. 2016;46:73–9. Accessed October 2025. Available at: https://www.sciencedirect.com/science/article/pii/S0305737216300172.
3. Nupur N, Singh SK, Rathore AS. Analytical similarity assessment of biosimilars: global regulatory landscape, recent studies and major advancements in orthogonal platforms. Front Bioeng Biotechnol. 2022;10:832059.
4. European Medicines Agency. Biosimilars in the EU: Information Guide for Healthcare Professionals. Published 2017. Accessed October 2025. Available at: https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf.

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