Worldwide Biologics Leader

We are biologics experts

At Amgen, we are proven innovators in a field that’s constantly accelerating. We are inspired every day to engineer robust and differentiated therapeutics.

We are tireless in these efforts, as evidenced by:1-5

16

Innovator therapeutic treatments through FDA approval since 1980, and now 2 biosimilar medicines

12

Innovator therapeutic treatments authorized for sale by Health Canada since 1991, and 1 biosimilar medicine

29

Innovator products in various stages of development

10

Products in our portfolio of biosimilar medicines

1st

oncology therapeutic biosimilar authorized for sale by Health Canada

Manufacturing matters

Manufacturing biologics and biosimilars requires highly specialized knowledge of:

Rigorous processes

Scientific standards

Quality systems

We have been building this knowledge for four decades. We are proud of our proven record of delivering high-quality, reliably supplied biologic medicines. This wouldn’t be possible without a global infrastructure supporting state-of-the-art manufacturing standards.6

Each biologic and biosimilar medicine requires its own operating procedure. Once that’s in place, we check and recheck to ensure we continue to deliver high-quality biologic and biosimilar medicines.7

We stand behind each and every product

Amgen applies the same level of robustness and rigour to the development of both innovator biologics and biosimilar medicines.

Our current biosimilar and any future biosimilar(s) will be produced in the same state-of-the-art facilities that manufacture our innovator biologics, and will be overseen by Amgen’s network of scientists.

References: 1. Amgen website. https://www.amgen.com/products/. Accessed November 8, 2018. 2. FDA News Releases. FDA approves Amjevita, a biosimilar to Humira. September 23, 2016, and FDA Approves Amgen And Allergan's MVASI™ (bevacizumab-awwb) For The Treatment Of Five Types Of Cancer. September 14, 2017. 3. Amgen Canada website. https://www.amgen.ca/products. Accessed August 21, 2018. 4. Health Canada Drug Product Database. 5. Amgen Pipeline. www.amgenpipeline.com/pipeline/. Accessed August 21, 2018. 6. Amgen Corporate Brochure: The Amgen Difference. https://www.theamgendifference.com/ assets/doc/theamgendifference.pdf. Accessed August 21, 2018. 7. Health Canada Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. Accessed May 24, 2018. Available at: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/brgtherap/applic-demande/guides/seb-pbu/seb-pbu-2016-eng.pdf.

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