Clinical Testing

Programs designed to inspire confidence

Amgen generates robust and rigorous data on each of our biosimilar medicines. These data packages:1,2

  • Use sensitive endpoints and patient populations
  • Ensure no clinically meaningful differences in:
    • Efficacy
    • Safety
    • Immunogenicity

This data is needed for approval, and importantly, equips clinicians and patients with the information they need to make confident informed treatment decisions.

Analytical, nonclinical, and clinical data

Once we have assessed the reference drug and established its critical quality attributes (CQAs), we design a manufacturing process for the biosimilar. Then, over several years of testing, we collect data needed to prove similarity and obtain approval.

  • A comprehensive comparison of the attributes of the biosimilar molecule with the reference product ensures there are no clinically meaningful differences.1,2
  • Even with robust analytical data, the biosimilar can be approved only with additional nonclinical and clinical data.1
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Biosimilar development process

When manufacturing a biosimilar, only the reference product’s amino acid sequence is known.3 From there, matching the reference drug requires considerable trial and error.

Once we have assessed the reference drug and established its critical quality attributes (CQAs), we design a manufacturing process for the biosimilar. Then, over several years of testing, we collect data needed to prove similarity and obtain approval.

  • A comprehensive comparison of the attributes of the biosimilar molecule with the reference product ensures there are no clinically meaningful differences.1,2
  • Even with robust analytical data, the biosimilar can be approved only with additional nonclinical and clinical data.1

Biosimilar development1,3

Reference product development3

Totality of evidence determines similarity

  • Together, the above data make up the totality of evidence which is used to assess the level of similarity.
  • Together, the above data make up the totality of evidence which is used to assess the level of similarity.

Clinical data

Clinical requirements for biosimilar development differ by regulatory agency. In general, phase 1 and phase 3 trials are required.1 Phase 2 trials are not typically required because the reference product’s dosing has already been established.

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Phase 1 and Phase 3 trials
Phase 1

Phase 1 trials use healthy volunteers or patients to collect pharmacokinetic (PK) and pharmacodynamic (PD) data.1

Phase 3 trials

Phase 3 trials demonstrate the biosimilar medicine has similar efficacy, safety, and immunogenicity to the reference product.2 These trials should be sensitive enough to detect clinically meaningful differences between the biosimilar and the reference product, if they exist.1
A phase 3 trial must demonstrate:2

  • Efficacy that is neither inferior nor superior to the reference product
  • Equivalent safety, efficacy and immunogenicity

Clinical requirements for biosimilar development differ by regulatory agency. In general, phase 1 and phase 3 trials are required.1 Phase 2 trials are not typically required because the reference product’s dosing has already been established.

References: 1. Health Canada Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. Accessed May 24, 2018. Available at: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/brgtherap/applic-demande/guides/seb-pbu/seb-pbu-2016-eng.pdf. 2. Health Canada. Fact Sheet: Biosimilars. Accessed May 24, 2018. 3. ICH. ICH Harmonised tripartite guideline. Specifications: Test procedures and acceptance criteria for biotechnological/biological products Q6B. 1999. Accessed May 24, 2018. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/ Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf.

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