Denosumab comprises two biosimilar products referencing the brands Prolia and Xgeva.
Under the agreement, Richter is responsible for the development of the products, conducting both Phase 1 and Phase 3 global clinical studies, and will supply the products for the U.S. market. Hikma will be responsible for registering the products with the U.S. Food and Drug Administration and will have exclusive rights to commercialize them in the United States.
Richter is eligible for an upfront payment and milestone payments totaling "a double-digit million USD figure" under the financial terms of the agreement.