Quality Assurance | Amgen Biosimilars

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 aim for 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 promoting 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 biosimilarity to their 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
Not only that, but 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

Reliability of drug supply is critical

Reliability of drug supply is critical
Potential impact of drug shortages may include:3
Drug rationing and need to prioritize patients
Time burden involved in managing shortages

Errors caused by inexperience with alternatives
Better supply chain performance can:4
Improve drug treatment choices, delivering reliable healthcare
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 minimize the risk of supply disruption for patients5

To strive for 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. We implement product security programs that help minimize the risk of shortages and help promote quality.
It is because of measures like these that we have one of the best records for lack of drug shortages in the pharmaceutical industry.6

Total number of drug shortages 2007-20176,*

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

References: 1. Data on file, Amgen; [Quality Control Checks] 2018. 2. Mysler E, Pineda C, Horiuchi T, et al. Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology. Rheumatol Int. 2016;36:613-625. 3. 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. Accessed October 29, 2019. 4. 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. Accessed October 29, 2019. 5. 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. 6. Data on file, Amgen; 2018.