Amgen employs stringent drug development process customized for each biosimilar
To begin, it is imperative we understand the disease, and the structure and function of the reference biologic.
Critical quality attributes
We then acquire the reference biologic and use sophisticated analytical tests to determine its critical quality attributes. These tell us what are important to the safety, efficacy and pharmacokinetics of the drug.1
We identify the desired attribute profile of the reference biologic and develop manufacturing parameters that result in a biosimilar. Our scientists typically evaluate more than 100 attributes2 of the biosimilar in comparison to the reference biologic to determine which are most important for producing a biosimilar.
Quality clone creation
Using our scientific capabilities, we create and select the optimal clone from thousands of cells. The optimal clone produces the antibody that matches the biological function of the reference product as closely as possible.1,3
Customizing the development process
Once the clone is chosen, we develop a process to produce the biosimilar that has no clinically meaningful differences to the reference biologic.
References: 1. Vulto AG, Jaquez OA. The process defines the product: what really matters in biosimilar design and production? Rheumatology. 2017;56:iv14-iv29. 2. Blauvelt A, et al. Biosimilars for psoriasis: preclinical analytical assessment to determine similarity. Br J Dermatol 2016;174:282-286. 3. US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. www.fda.gov/downloads/drugs/guidances/ucm291128.pdf. Accessed April 7, 2020.
HK-09628-AMGEN-2022-Dec Date of Approval: Dec 2022