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Development of Biosimilars [1]

Analytical, preclinical and clinical pharmacokinetic/ pharmacodynamic (PK/PD) studies

demonstrate that the active substance in the biosimilar medicine matches the reference
medicine. Final confirmation of biosimilarity requires a clinical Phase III confirmatory safety
and efficacy study in a sensitive indication1,2. This is different to development of reference
medicines whose focus is on proving clinical effect. Both approaches provide the same level
of confidence with regard to safety and efficacy of the biological medicine.

Download our biosimilars development brochure "From concept to reality" [2]

The four stages of the biosimilar development program are2:

1. Analytical - Extensive physicochemical characterization to establish ‘sameness’ of the

biosimilar to the reference molecule e.g. in terms of molecular structure.
2. Preclinical - Functional studies to confirm biological function, for example mode-of-
action, between the biosimilar and the reference molecule.
3. Clinical PK/PD - Clinical Phase I PK/PD studies in humans to determine bioequivalence
i.e. that the biosimilar and the reference medicine will work in the body the same way.
4. Clinical Phase III - Clinical Phase III confirmatory safety and efficacy study conducted
in a sensitive patient population to confirm that the safety and efficacy of the biosimilar
matches the reference medicine.
The totality of evidence is the data package generated from the biosimilar development
program to show that the biosimilar matches the reference medicine in terms of structure,
function, pharmacokinetic/pharmacodynamic profile, safety and efficacy3.

Understanding biosimilar approval

To be approved for use, a biosimilar has to match the reference medicine in terms of safety
and efficacy in patients, demonstrating no clinically meaningful differences. This is done using
advanced analytical, preclinical and clinical studies4,5.

Biosimilars are approved via stringent regulatory pathways by the same regulatory authorities,
such as the European Medicines Agency (EMA) or the Food and Drug Administration (FDA)
that approve reference medicines. They are manufactured with the same quality standards
that are used for reference medicines5,6.

Sandoz is the pioneer and global leader in biosimilars and has approved biosimilars in the
highly-regulated markets of the US, Canada, EU, Japan and Australia.

Footnotes:

1. Lemery SJ, et al. Clin Cancer Res. 2010; 16(17):4331-4338

2. McCamish, M and Woollett, G. Clin Pharmacol Ther. 2012; 91(3):405-417
3. Strand et al. Curr. Med. Res. Opin. 2017; 33(6):993-1003
4. European Commission. Consensus Information Paper 2013. What you need to know
about Biosimilar Medicinal Products. Available from:
http://ec.europa.eu/DocsRoom/documents/8242/attachments/1/translations/e...
 [Accessed June 2017]
[3]

5. Information on Biosimilars. FDA. Available from:

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelope... [4]
[Accessed June 2017]
6. European Medicines Agency. Questions and answers on biosimilar medicines (similar
biological medicinal products). Available from:
http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/12... [5]
[Accessed June 2017]

Accordion Type:
Collapsible
Source URL: https://www.sandoz.com/our-work/biopharmaceuticals/development-biosimilars

Links
[1] https://www.sandoz.com/our-work/biopharmaceuticals/development-biosimilars
[2] https://www.sandoz.com/sites/www.sandoz.com/files/media-library/documents/sandoz-biosimilars-
development-brochure.pdf
[3] http://ec.europa.eu/DocsRoom/documents/8242/attachments/1/translations/en/renditions/native
[4]
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplication
[5] http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/12/WC500020062.pdf