Worldwide Biologics Leader

We are biologics and, now, biosimilars 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 by1-8:

16

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

12

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

33

Innovator products in various stages of development

10

Products in our portfolio of biosimilar medicines

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.9

Each biologic and biosimilar 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 ensure we continue to deliver the highest-quality biologic and biosimilar medicines.10

Not only that, but we’ve also invested $1 billion to ensure 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.

References: 1. Amgen. Products. www.amgen.com/products/. Accessed March 16, 2018. 2. US Food and Drug Administration. www.fda.gov/newsevents/newsroom/pressannouncements/ucm522243.htm. Published September 23, 2016. Accessed March 16, 2018. 3. US Food and Drug Administration. www.fda.gov/newsevents/newsroom/pressannouncements/ucm576112.htm. Published September 14, 2017. Accessed March 16, 2018. 4. Amgen. Products. www.amgen.co.uk/products/. Accessed April 26, 2018. 5. European Medicines Agency. www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/004728/WC500242876.pdf. Updated January 2018. Accessed March 16, 2018. 6. European Medicines Agency. www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary _for _the_ public/human/004212/WC500225280.pdf. Updated March 2017. Accessed March 16, 2018. 7. Amgen. Amgen Pipeline. www.amgenpipeline.com/pipeline/. Accessed April 26, 2018. 8. Amgen. Approved products. www.amgenbiosimilars.com/our-products/approved-products/. Accessed April 26, 2018. 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 April 25, 2018. 10. EuropaBio. Guide to Biological Medicines: a Focus on Biosimilar Medicines. www.scribd.com/document/212444737/Guide-to-Biological-Medicines-a-Focus-on-Biosimilar-Medicines. Accessed April 24, 2018. 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 April 24, 2018.

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