Biosimilars | Amgen

Amgen Biosimilars

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 over $2 billion across a portfolio of 11 biosimilar medicines approved or in development, focusing primarily on oncology, hematology and chronic inflammatory diseases. This page will help you understand Amgen’s legacy in biosimilar development and provide you with additional biosimilar resources to learn more about our commitment.

Heritage

Heritage

There is no substitute for experience. Amgen has a rich heritage of landmark discoveries aimed at unlocking the potential of biology. This heritage allows us to create new ways to combat the most difficult diseases.

Expertise

Our decades of experience are the foundation of our expertise — which we continually build upon. Biologics development is a highly skilled, multistep process1 and we are end-to-end biologics experts. At every step we use the same scientific standards and quality systems for our biosimilars as we do for our innovator biologics. We aim to deliver a reliable supply of biosimilars as well as innovative biologics from development to manufacturing.

Expertise
Commitment

Commitment

Our biosimilars expertise is fueled by our commitment to our mission to serve patients. As a world leader and innovator in biologics, Amgen is proud to also produce biosimilar medicines for patients with life-threatening and chronic diseases. We have built a portfolio of biosimilar medicines and a reputation as a partner for both biosimilar and innovator biologics.

Support

We strive to support your biologics experience, with education and advocacy programs, and patient-support programs to help patients who use our medicines have access them.

Support

 

Fast Facts About Biosimilars

This video provides a high-level overview of biosimilars. The main goal of biosimilars 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. Each biosimilar is produced using a brand new and proprietary process. 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.

References:

  1. Camacho LH, Frost CP, Abella E, Morrow PK, Whittaker S. Biosimilars 101: considerations for U.S. oncologists in clinical practice. Cancer Med. 2014;3:889-899. Accessed January 1, 2024.