Amgen's Heritage
There is no substitute for experience. As a company with a strong innovator portfolio and a growing number of biosimilar products, Amgen has the insights and commitment to advocate for a marketplace that will promote biologic innovation and quality, while bringing competition and meaningful cost savings to the healthcare system.
Biosimilars Development
Our Expertise in Biologics Development
Biologics development is a highly skilled, multistep process and we are end-to-end biologics experts.1, 2 Amgen uses the same scientific standards and quality systems for our biosimilars as we do for our innovator biologics, from development to manufacturing, to deliver a reliable supply of medicines.3
With decades of global manufacturing experience and world-class logistics capabilities, Amgen is proud to consistently and reliably deliver medicines, even amidst global challenges. As we strive for reliability, we depend on our state-of-the-art manufacturing and distribution infrastructure in approximately 100 countries to promote a consistent supply of quality biologics, including biosimilars, across the globe.
The complexities of manufacturing and supplying innovator biologics apply to biosimilar medicines as well.2 But biosimilar development and manufacturing also has its own set of intricacies, requiring specialized knowledge of:
- Rigorous processes
- Scientific Standards
- Quality Systems
Quality is seen as an enterprise-wide responsibility at Amgen, and we invest heavily in risk mitigation on all levels to serve our patients and care providers. Through our quality by design principles and end-to-end quality management systems, our biosimilars are subject to over 250 quality checks from the lab to final delivery4 to ensure biosimilarity to the reference products. We also follow monitoring standards that promote rapid traceability, monitoring of safety events, and accurate identification so we can continue to take responsibility for our medicines once they leave Amgen facilities.
We harness the best of biology and technology to advance life-altering innovative medicines as well as biosimilar medicines that address the evolving needs of patients, care providers, and health systems, while improving efficiencies and outcomes in patient care.
We listen and learn from real-world experiences as a biologic innovator and biosimilar manufacturer to identify and address the unique challenges patients may face when using our medicines. We incorporate these learnings to improve the patient experience with our physician- and self-administered biosimilars. This commitment to addressing needs, paired with our exceptional planning, processes and infrastructure, provides a consistent level of reliability for patients, healthcare providers and health systems, even amidst global challenges.
Amgen believes investing in developing more high-quality biosimilars will not only offer more affordable options for patients and health systems, but also free up resources to invest in new innovations.
Supporting Patients and Healthcare Providers
We are committed to offering solutions-oriented resources that can help provide positive biosimilar experiences, including education, advocacy and patient-support programs to help patients who use our medicines to have access to them.
Amgen support for biosimilars may include:
