Steeped in Biologics Experience | Amgen Biosimilars
CLEAR

Highly Specialized Biologics Knowledge


Amgen brings extensive experience in innovator biologics to its biosimilars

We are end-to-end biologics experts

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

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

BioEngage
Explore the difference in size and complexity between small-molecule and biologic medicines2-10
  • Custom cell lines and entirely new manufacturing processes are required to ensure each biosimilar maches the reference drug's safety and efficacy10
Biosimilars development is equally complex,1 and our innovator 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.

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 January 10, 2019. 5. Charles D, Chapman MA. Institute for Patient Access. What is indication extrapolation and should it be allowed with biological medications? 1yh21u3cjptv3xjder1dco9mx5s.wpengine.netdna-cdn.com/wp-content/uploads/2013/08/TPP_IndicationExtrapolation0914Final.pdf. Accessed January 10, 2019. 6. European Medicines Agency. Q&A on biosimiliar medicines. www.medicinesforeurope.com/wp-content/uploads/2016/03/WC500020062.pdf. Accessed January 23, 2019. 7. Berkowitz SA, Engen JR, Mazzeo JR, Jones GB. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nat Rev Drug Discov. 2012;11:527-540. 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 January 10, 2019. 10. US Food and Drug Administration. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity of a Therapeutic Protein to a Reference Product. www.fda.gov/downloads/drugs/guidances/ucm291128.pdf. Published April 2015. Accessed January 10, 2019.

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