Biosimilars from a Biologics Leader | Amgen Biosimilars

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:


Innovator therapeutic treatments through FDA approval since 1980, and 4 biosimilar medicines


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


Innovator products in various stages of clinical development


Products in our portfolio of biosimilar medicines*

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

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 our biosimilars follow the same high quality and rigorous standards as our innovator biologics.
*Portfolio includes pipeline assets studied in multiple therapeutic areas.

Reference: 1. EuropaBio. Guide to biological medicines: a focus on biosimilar medicines. 2011.