Budapest, Hungary and London, UK, 12 December 2024 – Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals PLC (“Hikma”) today announced that the U.S. Food and Drug Administration (FDA) had accepted for review the Biologics License Applications (BLA) for RGB-14, a Denosumab biosimilar candidate comprising two biosimilar products referencing Prolia® and Xgeva® (“Products”), a human monoclonal antibody for the treatment of osteoporosis and fractures due to bone metastasis.

In December 2021, Hikma entered an exclusive license agreement to commercialise Richter’s denosumab in the United States (“US”). According to the agreement, Richter has been responsible for the development of the Products (including both Phase 1 and Phase 3 global clinical studies) and will supply finished commercial Products for the US market. Hikma is responsible for FDA registration and has exclusive rights to commercialise them in the US upon FDA approval.

The FDA submission underscores Hikma’s commitment to improving access to high quality injectable products for US patients and highlights Richter’s commitment to develop its biosimilar programmes for global markets with strong focus on the United States.

“We are pleased FDA has accepted for review our application for Denosumab, an important biosimilar needed by a growing number of patients across the US, and we look forward to adding this product to our large and growing US portfolio of essential injectable medicines,” said  Dr. Bill Larkins, President of Hikma Injectables. “We are especially pleased to be partnering on this product with the highly talented team at Gedeon Richter.”

“The FDA submission of our denosumab biosimilar product is a significant milestone, which strengthens our partnership with Hikma, a highly respected company having strong US presence, enabling Richter to reach patients across the globe with our biosimilar programmes.” said Erik Bogsch, Head of the Biotechnology Business Unit at Richter.

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