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Amgen Biosimilars

Amgen has harnessed the power of science for over 40 years as a biologics innovator to advance solutions for some of the world’s toughest diseases. Against the backdrop of this rich heritage, we have invested over $2 billion across a portfolio of 11 biosimilar medicines that are approved or in development, focusing primarily on oncology, inflammation and rare diseases. This page will help you understand Amgen’s deep expertise in biosimilar development and provide you with additional resources to learn more about this important class of medicines.

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Rigorous Development and Regulatory Standards
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    Biosimilars for Healthcare Providers
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      Biosimilars for Patients
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        Value of Biosimilars

          Our Leadership in Biosimilars

          Learn more about how we are leading the way in biosimilars with our rich heritage, expertise, commitment and support for patients and HCPs.

          Amgen's Heritage

          Experience speaks for itself, and our legacy of groundbreaking discoveries empowers us to develop innovative solutions to the world's toughest diseases alongside a growing biosimilars portfolio.  

          Our Expertise in Biologics Development

          Our rich experience serves as the foundation of our expertise and allows us to deliver a reliable supply of biosimilars, just as we've been doing for decades with innovator biologics from development to manufacturing.

          Commitment to Addressing Needs in Healthcare

          We are proud to produce biosimilar medicines for patients with life-threatening or chronic diseases and are committed to identifying and addressing the evolving needs of patients, healthcare providers and health systems. 

          Supporting Patients and Healthcare Providers

          Through education and resources like advocacy and patient-support programs, we strive to help our patients access their medicines.  

          Fast Facts About Biosimilars

          The goal of biosimilar development is to create a drug that is highly similar to a reference product, with no clinically meaningful difference in safety, purity, and potency from the original product.1,2 Each biosimilar is produced using a brand new and proprietary process.3,4 Biosimilarity is established based on the totality of the evidence demonstrating its similarity to the original product, not by developing the same clinical and nonclinical data as the original product.2 

          Amgen's Product Portfolio

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          Amgen's Pipeline

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          References:

          1. Future Medicine. "Similar biotherapeutic products: overview and reflections." 2012. Available at: https://www.futuremedicine.com/doi/epub/10.2217/imt.12.128
          2. European Medicine Association (EMA). "What I Need to Know About Biosimilar Medicines." 2016. Available at: https:// ec.europa.eu/docsroom/documents/26643
          3. U.S Food and Drug Administration. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. April 2015.
          4. U.S. Food and Drug Administration. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. April 2015. Available at: https://www.fda.gov/downloads/drugs/guidances/ucm291128.pdf. Accessed March 31, 2025.