With more than three decades of experience in biotechnology and a record of reliably supplying medicines to patients,1 Amgen is known worldwide as a leader in research, development, and manufacturing of complex biologic therapies.
Shortages of prescription medicines are a growing problem around the world. Drug shortages can have a significant impact on patients and healthcare providers. As identified by the FDA, quality, manufacturing, and capacity issues are major reasons for many of these drug shortages.2
We are deeply committed to ensuring doctors and patients can rely on the quality and availability of our treatments, including the biosimilars we plan to manufacture. The Amgen approach to providing a continuous supply of biologic therapies has four key elements:
- PREVENTION, which includes ensuring exemplary regulatory compliance, robust quality management processes, operational excellence, supply chain security, infrastructure investments, and business continuity planning
- TECHNOLOGY to enhance product purity and the robustness of the manufacturing process
- INVENTORY MANAGEMENT to ensure we have the right quantities of the product housed in diverse geographic locations
- REDUNDANT MANUFACTURING capacity in multiple geographic locations and back-up suppliers for raw materials
We've taken steps to understand potential vulnerabilities in processes and facilities and made significant investments to help ensure the quality and supply of Amgen biotech products.3
- Data on file, Amgen; 2013.
- A review of FDA's approach to medical product shortages. October 31, 2011. http://www.fda.gov/drugshortagereport. Accessed April 17, 2013.
- Data on file. Amgen; 2013.