Richter’s two MAAs include all indications covered by the reference biologics.

Richter submitted a comprehensive analytical and clinical data package, which comprises data from a Phase I pharmacokinetic/pharmacodynamic (PK/PD) similarity study in healthy volunteers and a multicenter Phase III study. According to the data package, Richter’s denosumab biosimilar matches the reference products in relation to PK, PD, efficacy, safety, and immunogenicity in the respective populations used in the studies. The data also contribute to the demonstration of similarity, which forms the basis for the biosimilar’s use in all indications of the originator’s products.

“Acceptance of our denosumab biosimilar for assessment by the EMA marks a very important milestone for Richter, it is the first biosimilar monoclonal antibody within the Company’s broadening biosimilars portfolio” – said Dr Erik Bogsch, Head of the Biotechnology  Business Unit at Richter. “When approved, this will increase patient access to this important biologic drug, strengthening Richter’s future presence in the affordable medicines segment.”

For additional prescribing information and patient information about the originator products, please visit the following links:

https://www.ema.europa.eu/en/documents/product-information/prolia-epar-product-information_en.pdf