ABP 501 is being developed by Amgen Inc. as a biosimilar to adalimumab. The primary and higher-order structure of ABP 501 drug product have been shown to be similar to adalimumab reference products (RPs).

ABP 501 behaved in a similar manner to adalimumab RPs in functional bioassays.

The high degree of similarity in structure and function provides assurance that ABP 501 will likely be similar to adalimumab RPs in the clinic, including pharmacokinetics, pharmacodynamics, efficacy, and safety.

Clinical similarity has been confirmed in human pharmacokinetics/pharmacodynamics (phase I) and clinical efficacy and safety (phase III) studies.