Highly Specialized Knowledge

Amgen brings extensive experience in biologics to its biosimilars

The next generation of biosimilar manufacturing

Biologics development is a highly skilled, multistep process1—and Amgen has extensive experience in all phases, from development to manufacturing, to help ensure a reliable supply.

Biosimilars development is equally complex,1 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 biologics.

Difference between molecular mass of small-molecule medicines and large-molecule biologics2-10

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

References: 1. Camacho LH, Frost CP, Abella E, Morrow PK, Whittaker S. Biosimilars 101: considerations for U.S. oncologists in clinical practice. Cancer Med. 2014;3:889-899. 2. Aspirin Prescribing Information, Bayer. 3. Insulin product information, Sigma-Aldrich, 2014. 4. Online Mendelian Inheritance in Man. Growth Hormone 1; Gh1. www.omim.org/entry/139250. Accessed April 26, 2018. 5. Charles D, Chapman MA. Institute for Patient Access. What is indication extrapolation and should it be allowed with biological medications? www.1yh21u3cjptv3xjder1dco9mx5s.wpengine.netdna-cdn.com/wp-content/uploads/2013/08/TPP_lndicationExtrapolation0914Final.pdf. Accessed April 26, 2018. 6. European Medicines Agency. Q&A on biosimiliar medicines. www.ema.europa.eu/docs/en_GB/document_library/Presentation/2012/05/WC500127917.pdf. Accessed April 26, 2018. 7. Berkowitz SA, Engen JR, Mazzeo JR, Jones GB. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nat Rev Drug Discov. 2013;11:526-540. 8. Lipman NS, Jackson LR, Trudel LJ, Weis-Garcia F. Monoclonal versus polyclonal antibodies: distinguishing characteristics, applications, and information resources. ILAR J. 2005;46:258-268. 9. McKinsey & Company. From science to operations: Questions, choices and strategies for success in biopharma. www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/from-science-to-operations-questions-choices-and-strategies-for-success-in-­biopharma. Published March 2014. Accessed April 23, 2018. 10. US Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity of a Therapeutic Protein to a Reference Product: Guidance for Industry. www.fda.com/downloads/drugs/guidances/ucm291128.pdf. Published April 2015. Accessed April 23, 2018.

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