Steeped in Biologics Experience | Amgen Biosimilars
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Quality Assurance

Biotechnology supply


We check. Then we check again

At Amgen, we are focused on a common goal: to make sure quality medicines get to every patient, every time. We achieve this in part by capitalizing on our global infrastructure, in which all facilities follow the same processes to:
  • Produce quality medicine
  • Deliver a reliable supply of medicine

Focused on ensuring quality

Protecting patients is paramount. We invest heavily in risk mitigation on all levels to serve our patients and care providers, so we can immediately correct course should any issues arise. From the lab to the bioreactor to final delivery, biosimilars are typically subjected to over 250 quality checks to ensure their similarity to the respective reference products.1
Amgen employs two primary types of systems to ensure quality:
  • Quality Management Systems that ensure adherence to normal variability standards
  • Quality by Design Principles that are part of important processes developed to promote quality, safe, and compliant medicines2,3
Not only that, we take complete responsibility for our medicines after they leave our facilities, with effective monitoring standards in place to promote:
  • Rapid traceability
  • Monitoring of safety events
  • Accurate identification of specific biologics, including biosimilars, used by individual patients

An outstanding record of reliable supply

BioEngage
Reliability of drug supply is critical

BioEngage
Reliability of drug supply is critical
Potential impact of drug shortages may include:4
Drug rationing and need to prioritize patients
Time burden involved in managing shortages

Errors caused by inexperience with alternatives
Better supply chain performance can:5
Improve drug treatment choices, delivering reliable health care
Improve safety, reducing human and financial burden of medication errors
At Amgen, we make medicines for serious illnesses and chronic conditions that deeply affect patients’ lives. We know it is imperative patients receive an uninterrupted supply of medicine and that gaps in supply can have serious consequences.

Amgen implements product security programs to help
ensure reliable supply of its medicines to patients6

To maintain reliability, we depend on our state-of-the-art manufacturing and distribution infrastructure to promote a consistent supply of quality biologics, including biosimilars, across the globe.
It is because of measures like these that we have one of the best records for lack of drug shortages in the pharmaceutical industry.7

Total number of drug shortages 2007-20177,*

*Data collected from the American Society of Health-System Pharmacists.

References: 1. Data on file, Amgen; [Quality control checks; 2018]. 2. Rathore AS, Winkle H. Quality by design for biopharmaceuticals. Nat Biotechnol. 2009;27:26-34. 3. Jameel F, Khan M. Quality-by-design as applied to the development and manufacturing of a lyophilized protein product. Am Pharm Rev. www.americanpharmaceuticalreview.com/Featured-Articles/117782-Quality-by-Design-as-Applied-to-the-Development-and-Manufacturing-of-a-Lyophilized-Protein-Product/. Published December 1, 2009. Accessed January 10, 2019. 4. US Government Accountability Office. Drug Shortages: Public Health Threat Continues, Despite Efforts to Help Ensure Product Availability. GAO-14-194. www.gao.gov/assets/670/660785.pdf. Published February 10, 2014. Accessed January 10, 2019. 5. Ebel T, George K, Larsen E, Shah K, Ungerman D. Building New Strengths in the Healthcare Supply Chain. McKinsey & Company. www.health.economictimes.indiatimes.com/web/files/retail_files/reports/data_file-Building-New-Strenghts-In-Healthcare-Supply-Chain-1421845643.pdf. Published January 2013. Accessed January 10, 2019. 6. Mica A, Mutomba M, Green L. Steps to ensure adequate supply of biological medicines: considerations for the healthcare provider. GaBI J. 2013;2:136-143. 7. Data on file, Amgen; 2018.