Steeped in Biologics Experience | Amgen Biosimilars

Quality Assurance


Our goal: Quality medicines for every patient, every time

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 ensuring all our global facilities follow the same processes to:
  • Produce quality medicine; and
  • Deliver a reliable supply of medicine.

Focused on promoting quality

We invest heavily in risk mitigation on all levels to serve our patients and care providers. From the lab to the bioreactor to final delivery, biosimilars are typically subjected to rigorous quality checks to ensure biosimilarity to their respective reference products.
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, and accurate identification of specific biologics, including biosimilars, used by individual patients.

Delivering a reliable supply of quality medicines

We make medicines for illnesses and chronic conditions that deeply affect patients’ lives. We know it is imperative patients receive an uninterrupted supply of medicine.
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.
Date of Approval: Dec 2022