worldwide-biologics-leader

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:

18

Innovator therapeutic treatments through FDA approval since 1980, and 3 biosimilar medicines^1,3

13

Innovator therapeutic treatments through EMA approval since 2001, and 2 biosimilar medicines^4,6

31

Innovator products in various stages of clinical development⁷

10

Products in our portfolio of biosimilar medicines^7,8,*

As of August 7, 2019.

Manufacturing matters

Manufacturing biologics, including 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 quality, reliably supplied biologic medicines. This wouldn’t be possible without a global infrastructure supporting state-of-the-art manufacturing standards.⁹

Each biologic medicine requires its own high-standard operating procedure, something we’re continually investing in and refining. Once that’s in place, we check and recheck to make certain that we can continue to deliver quality biologic medicines.¹⁰

Not only that, but we’ve also invested $1 billion to promote supply stability, earning us a reputation for trustworthiness, reliability, and determination to get medication to every patient, every time.¹¹

Innovative systems that are proven

Our people, processes, and products have been validated time and again, and our innovative processes have become a leading industry standard. We use the same network of scientists and state-of-the-art facilities to manufacture our biosimilar medicines as we do for our innovator biologics. That means that when you use our biosimilars, you can be confident in their high quality and rigorous standards.

*Portfolio includes pipeline assets studied in multiple therapeutic areas.

References: 1. Amgen. Products. www.amgen.com/products/. Accessed January 10, 2019. 2. US Food and Drug Administration. www.fda.gov/newsevents/newsroom/pressannouncements/ucm522243.htm. Published September 23, 2016. Accessed January 10, 2019. 3. US Food and Drug Administration. FDA approves first biosimilar for the treatment of cancer. www.fda.gov/newsevents/newsroom/pressannouncements/ucm576112.htm. Published September 14, 2017. Accessed January 10, 2019. 4. Amgen. Products. www.amgen.co.uk/products/. Accessed January 10, 2019. 5. European Medicines Agency. EPAR summary for the public: Mvasi. www.ema.europa.eu/docs/en_GB/document_libary/EPAR_-_Summary_for_the_public/human/004728/WC500242876.pdf. Updated January 2018. Accessed January 10, 2019. 6. European Medicines Agency. EPAR summary for the public. www.ema.europa.eu/docs/en_GB/document_libary/EPAR_-_Summary_for_the_public/human/004212/WC500225280.pdf. Updated March 2017. Accessed January 10, 2019. 7. Amgen. Amgen Pipeline. www.amgenpipeline.com/pipeline/. Accessed January 10, 2019. 8. Amgen. Approved Products. www.amgenbiosimilars.com/our-products/approved-products/. Accessed January 10, 2019. 9. Amgen. Unlocking the Potential of Biology for Patients. www.amgen.com/~/media/amgen/full/ www-amgen-com/downloads/amgen_corporate_brochure.ashx. Published August 2016. Accessed January 10, 2019. 10. EuropaBio. Guide to Biological Medicines: A Focus on Biosimilar Medicines. 2011. 11. Amgen Press Release. Amgen Continues Manufacturing Expansion with Additional $1 Billion Investment in Puerto Rico. www.amgen.com/media/news-releases/2006/02/amgen-continues-manufacturing-expansion-with-additional-$1-billion-investment-in-puerto-rico/. Published February 2006. Accessed January 10, 2019.

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