Highly Specialized Knowledge

Amgen brings experience in biologics to its biosimilars

Biologic and biosimilar manufacturing

Biologics development is a highly complex, multistep process1—and Amgen has experience in all phases, from development to manufacturing, to ensuring a reliable supply.

Biosimilars development is equally complex, and our biologics expertise, gathered over four decades, means that we’re prepared for the task. We use the same processes, scientific standards, and quality systems for our biosimilars as we do for our innovator biologics.

Biosimilars development is equally complex, and our biologics expertise, gathered over four decades, means that we’re prepared for the task. We use the same processes, scientific standards, and quality systems for our biosimilars as we do for our innovator biologics.

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Difference between molecular mass of small-molecule medicines and large-molecule biologics

When manufacturing a biosimilar, the reference product’s amino acid sequence should be known.2 From there, matching the reference drug requires considerable trial and error.

References: 1. Health Canada. Biologics, Radiopharmaceuticals and Genetic Therapies. Accessed August 27, 2018. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies.html. 2. 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. 3. Health Canada. The safety and effectiveness of generic drugs. Accessed August 23, 2018. Available at: https://www.canada.ca/en/health-canada/services/healthy-living/your-health/medical-information /safety-effectiveness-generic-drugs.html. 4. Health Canada. Fact Sheet: Biosimilars. Accessed May 24, 2018. 5. Aspirin Product Monograph. April 7, 2017. 6. Insulin product information, Sigma-Aldrich, 2014. 7. Online Mendelian Inheritance in Man. Growth Hormone 1; Gh1. www.omim.org/entry/139250. Accessed April 26, 2018. 8. Enbrel Product Monograph. April 13, 2018.

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