Amgen is a pioneer in the field of biologic medicines and our mission is to serve patients.
The pursuit of science-based medicines that restore health or even save lives is fundamental to our values. Our primary focus is to continue discovering, developing, manufacturing and commercializing innovative medicines to treat grievous illnesses. Amgen’s leading position in biotechnology, long-standing commitment to patient safety and leadership in manufacturing high quality biologic medicines mean that Amgen is equipped to develop and produce safe and effective biosimilars.
We are excited to find new ways to serve patients in this rapidly evolving field, and believe biosimilars have a role to play in providing an important option for some patients and in reducing the overall costs of delivering biotechnology medicines -- provided they are shown to be safe and effective and intellectual property of the innovator company is respected.
Biosimilar development requires significant expertise, infrastructure and investment to demonstrate safety and equivalent efficacy and to ensure safe, reliable supply of therapies for patients.
The Challenges in Manufacturing Biologics
Biologic therapies are typically derived from living organisms. They are made by genetically engineering living cells, and a high level of precision is required in the commercial manufacturing process to produce a consistent biologic product each time. The protein produced by the cells will be influenced by individual cell characteristics, and the environment and nutrients provided during the manufacturing process.
