As a leading biotechnology company, Amgen has harnessed the power of science for over 40 years to advance solutions for some of the world’s most serious illnesses. Against the backdrop of this rich heritage, we have invested in a portfolio of biosimilar medicines that offer the potential to increase patient access to vital treatments. Amgen is well-positioned to create high-quality biosimilars and reliably supply them to patients worldwide.

Biosimilars Basics

Amgen is committed to developing high-quality biosimilar medicines for patients. Amgen was one of the first large-scale biotechnology manufacturers, and we have developed some of the most widely used, quality biologic medicines used in the treatment of millions of patients around the world.

  • WHAT IS A BIOSIMILAR?

    • A biosimilar is a biologic medicine designed to work just like another biologic medicine, known as the reference medicine.1
    • Biologic medicines can be made of a mix of substances, even living things like cells and tissues.1
    • Biosimilar treatment options are available for chronic diseases including rheumatoid arthritis, inflammatory bowel disease, psoriasis, and certain cancers.1
  • ARE BIOSIMILARS SAFE AND EFFECTIVE?

    • Biosimilars have no clinically meaningful differences from the reference product. This means you can expect the same safety and effectiveness from the biosimilar over the course of treatment as you would the reference product.1
    • Biosimilars have the potential to increase treatment options and to help keep treatment costs down.1
    • To be approved, a biosimilar must show it has no clinically meaningful differences to the reference biologic in terms of quality, safety, and its ability to produce the desired outcome in patients (also known as efficacy).1,2
  • THE VALUE OF BIOSIMILARS

    In addition to providing the same safety and effectiveness as their reference medicines, biosimilars have the potential to lower healthcare costs by offering different treatment options.1

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Our Manufacturing Heritage

At Amgen, we are focused on a common goal: to make sure high-quality medicines get to every Amgen patient, every time. With over 40 years of experience in developing innovative biologic therapies, Amgen also has one of the world's largest biosimilars portfolios, providing effective and safe biologic treatments for patients and healthcare systems around the world.

Our story holds over 40 years of experience in developing innovative biologic therapies, which are made from living cells enhancing our development of biosimilars in different therapeutic areas around the world, such as inflammation and oncology.

Biosimilars are biologic medicines designed to work just like another FDA approved medicine, known as the reference product, and are tested to ensure they are safe, effective and highly similar to the reference product.

Since the first biosimilar was approved in Europe in 2006,

Amgen has developed one of the world’s largest biosimilars portfolios Providing effective and safe treatments for patients and healthcare systems .

More than 750,000 people in more than 65 countries have been prescribed Amgen’s biosimilars to date.

Biosimilars Development and Manufacturing

Developing a biosimilar is an incredibly complex process. Biosimilars, like all biologics, are produced through an intricate, multistep process, using living cells. The technology we're using to develop and manufacture biologics today is more precise, more accurate, and more quantitative than in years past – giving us the ability to look at multiple attributes to bring reliable, high-quality medicines to patients.3-7

End-to-End Biologics Experts: Our Process

At Amgen, we excel at the highly specialised, iterative process of developing monoclonal antibodies in vitro, scaling up the optimal cell line, time and again, in large-scale bioreactors, and checking and rechecking for batch-to-batch consistency.4,8

 

A Strong and Secure Supply Chain

At Amgen, we make medicines for serious illnesses and chronic conditions that deeply affect patients’ lives. We know it is imperative patients receive an uninterrupted supply of medicine and that gaps in supply can have serious consequences.

Manufacturers of biologic medicines are responsible for monitoring all steps during product development and manufacturing to ensure that the medicine is pure, has the desired strength and is stable.4 A reliable supply chain is key to this responsibility. Biosimilar supply chains should:

  • Ensure product authentication
  • Maintain strict warehouse security
  • Incorporate vigilant cargo security
  • Conduct market surveillance