Steeped in Biologics Experience | Amgen Biosimilars

Deep Experience


Amgen has a history of landmark discoveries

There is no substitute for four decades of biologics experience.

At Amgen, we specialize in unlocking the potential of biology to create new ways to combat the most difficult diseases, to better serve patients. We have been steeped in this challenge since the early days of recombinant DNA technology, when a handful of scientists and investors came together to prove the promise of innovative biotechnology.1

One of our first big discoveries came in 1983. For two years, a team led by a young scientist named Fu-Kuen Lin combed tirelessly through 1.5 million fragments of the human genome before isolating and cloning the erythropoietin gene, which is responsible for the stimulation of red blood cell production. This discovery ultimately set the future direction of our company.1

One of the first companies to develop:2,3

  • Therapeutic proteins, which replace or supplement natural human proteins
  • Monoclonal antibodies, therapeutic proteins that target disease with specificity
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These therapies have been used to treat millions of patients around the world, and there’s an opportunity to help treat millions more with Amgen’s growing portfolio of biosimilars, both approved and in the pipeline.


Biology first—and foremost

Amgen was one of the first large-scale biotechnology manufacturers, and we’re now one of the largest independent biotechnology companies. We have developed some of the most widely used, quality biologic medicines, with a portfolio totaling more than a dozen medicines across six therapeutic areas: oncology and hematology, cardiovascular disease, nephrology, inflammation, bone health, and neuroscience.

Each step of the way, we’ve refined our biotechnological processes and expertise. Our experience developing and refining our systems reassures the healthcare community that we promote a goal of reliable supply of our biologic medicines worldwide.4,5

More recently, we have used human genetic validation whenever possible in the discovery and development process:

  • Pursue a “biology first” approach to drug discovery—selecting drug targets with a deep understanding of disease biology and then choosing a drug modality, or structural template, best suited to the target
  • Maintain one of the industry's leading toolkits of modalities, allowing us to select the optimal tool to target the key molecular defect

Amgen's “biology first” approach, coupled with an array of drug modalities, carries several benefits:


Enhanced likelihood of success


Efficient development of new medicines


Increased patient options
to new medicines

Many things at Amgen remain unchanged from those early years. We still operate with the same drive, determination, and innovative spirit and values—finding ways to transform new ideas and discoveries, to help make life better for millions of patients.


Biosimilar standards born of our biologics standards

One of our most exciting pursuits is the exploration of biosimilar medicines, which will offer new treatment options for physicians and patients. We are taking our rich biologics experience and putting everything we’ve learned into making quality biosimilar medicines. Not only that, but we’re backing it all with our established reputation of striving for quality, reliability, and comprehensive support services.

References: 1. National Center for Biotechnology Information. EPO Erythropoietin [homo sapiens (human)]. Accessed October 29, 2019. 2. Lybecker KM. The biologics revolution in the production of drugs. Fraser Institute. Accessed October 29, 2019. 3. Nowicki M. Basic facts about biosimilars. Kidney Blood Press Res. 2007;30:267-272. 4. Data on file, Amgen; 2018. 5. Data on file, Amgen; 2019.