Fresenius Kabi announced today that MSB11455, a biosimilar candidate of Neulasta®* (pegfilgrastim), met its primary endpoints in the two pivotal clinical studies. Both studies are designed to enable the application for marketing authorization in the EU and US.
The first study titled: “A Randomized, Double-blind, Crossover Study to Compare the Pharmacokinetic and Pharmacodynamic Bioequivalence of a Single Injection of MSB11455 and Neulasta® in Healthy Adult Subjects” met all primary pharmacokinetic endpoints, Cmax and area under the curve (AUC), as well as the primary pharmacodynamic endpoints of absolute neutrophil count (ANC). Similar adverse events were found in both treatment groups.
The second study titled: “A Randomized, Double-blind, Parallel Group, Controlled Study to Compare the Immunogenicity and Safety of MSB11455 and Neulasta® in Healthy Adult Subjects” met its primary endpoints for immunogenicity. Positive anti-drug antibodies status was balanced between both treatment groups and no neutralizing antibodies were found. Similar adverse events were observed in both study arms.
Dr. Michael Schönhofen, Member of the Fresenius Kabi Management Board and President of the Pharmaceuticals Division, said: “We have reached another important milestone in the development of our biosimilar pipeline. It is our belief that biosimilars will further strengthen the Fresenius Kabi commitment in caring for cancer patients.”
Dr. Michael Soldan, Head of the Business Unit Biosimilars, Pharmaceuticals Division, Fresenius Kabi said: “These results are encouraging and reinforce our commitment to develop high quality biosimilar solutions for patients in oncology and autoimmune diseases. It is one of the challenges of the healthcare systems worldwide to provide patients access to affordable, high-quality treatments for lifethreatening diseases, and biosimilars will be an important part of the solution.“
About MSB11455, a biosimilar candidate of Neulasta® (pegfilgrastim)
MSB11455 is being developed as a biosimilar candidate of Neulasta® by Fresenius Kabi**. Neulasta® (pegfilgrastim) is a biologic therapy approved in the EU and US. In the US, Neulasta® is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Neulasta® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
* Neulasta® is a registered trademark of Amgen *
* MSB11455 is not yet submitted to health authorities for approval.