At the heart of Amgen's commitment to biosimilars is our mission to serve patients. We aim to empower patients that may not know much about biosimilars with information to feel confident in their treatment options.
Here are some frequently asked questions about biosimilars:
Some medications are proteins and are known as biologic medicines. Biologic medicines are different than non-biologic, small molecule medicines, such as aspirin. A small-molecule medicine is typically made through a chemical process, which means that it is made by combining specific chemicals together to make a medicine. A biologic medicine is made in a living system such as an animal cell, microorganism, or plant. Biologic medicine components are much larger, often up to 1,000 times the size of small-molecule medicines, and are very complex to make.1
A biosimilar is a biologic medicine that has been demonstrated to be highly similar to, and with no clinically meaningful differences from, an existing biologic medicine – sometimes called a ‘reference product’ – already approved for use by regulatory agencies, such as the US Food and Drug Administration (FDA). When a regulatory agency approves a biosimilar candidate it is determining it to be as safe and effective as the original biologic for all of the indications of the reference product for which it has been approved.2
No, a generic medicine is an exact copy of an original small-molecule medicine and is expected to be identical to the original product. Since biosimilars are large complex medicines made in living cells, an exact copy of the reference medicine cannot be made. However, when approved, a biosimilar has been demonstrated to be highly similar to the reference product with no clinically meaningful differences in terms of safety, purity, and potency.2,3
Biosimilars may provide patients a range of treatment options and a degree of flexibility of choice in therapies that they may not otherwise have. Increased biosimilar availability and adoption can also reduce healthcare costs for every stakeholder in the healthcare system, including patients. Learn more about the value biosimilars offer to our healthcare system here. 4,5
If you are seeking prescribing information, medication guides or patient instructions for your Amgen biosimilar medication, please visit our biosimilar products page.
References: 1. Sekhon, et al. Biosimilars. 2011:1;1-11 2. United States Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. 2015. 3. United States Food and Drug Administration. Biosimilar and Interchangeable Products. 2017. 4. U.S. Food and Drug Administration. Biosimilar and Interchangeable Biologics: More Treatment Choices. 2020. 5. Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. RAND Health Q. 2018;7:3