Amgen is steeped in the science of creating, producing, and manufacturing life-changing medicines that treat cancer and chronic inflammatory diseases. Throughout our long history in oncology and inflammation, we have brought novel and practice‑changing supportive and therapeutic biologics to patients with serious types of cancer and inflammation diseases. We are now applying that experience to developing our biosimilar medicines.
We have deep knowledge of the science of creating and producing monoclonal antibodies and fusion proteins, which are more complex than small-molecule drugs in terms of:1
Process to establish biosimilarity
We follow regulatory guidelines to ensure:2
The biosimilarity of the biosimilar molecule versus the reference product
Safety and effectiveness of biosimilars comparable to that of their reference biologics
Goal to be there for every patient, every time
Amgen has not had a product shortage in 10 years, a track record of patients receiving the quality Amgen medications they needed, every time. We strive to continue this record of quality and reliability with our biosimilars.3
Devices designed for the disease
Because Amgen is so involved in every aspect of each disease we make medicines for, we are very aware of the challenges patients with these conditions face. And that’s where our commitment to device innovation comes in. Enhancing the patient experience with our devices is always our goal, and we have a proven track record of success across therapeutic areas, including oncology and inflammation.
References:1. Camacho LH, Frost CP, Abella E, et al. Biosimilars 101: considerations for U.S. oncologists in clinical practice. Cancer Med. 2014;3:889-899. 2. US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. www.fda.gov/downloads/drugs/guidances/ucm291128.pdf. Accessed October 29, 2019. 3. Data on file, Amgen; 2019.