Fresenius Kabi's Biosimilar Pegfilgrastim Meets Primary Endpoints in 2 Studies

Fresenius Kabi announced today that its MSB11455, a proposed pegfilgrastim biosimilar referencing Neulasta, met its primary endpoints in 2 clinical studies that are intended to facilitate regulatory applications for the product in the United States and the European Union.

The first study was a randomized, double-blind crossover study that compared the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence of a single injection of the biosimilar and the reference pegfilgrastim in 344 healthy volunteers in Australia. Fresenius Kabi indicated that this study met all primary PK endpoints as well as the primary PD endpoint of absolute neutrophil count. Adverse events (AEs) were similar between the 2 groups.

The second study enrolled 336 healthy volunteers in New Zealand to study the safety and immunogenicity of MSB11455. The drug maker indicated that the study met its primary endpoints for immunogenicity as measured by antidrug antibody (ADA) response and the development of neutralizing antibodies. The incidence of positive ADA status was balanced between the patients who were given the biosimilar and the reference pegfilgrastim, and no neutralizing ADAs were detected. Similar AEs were found in both groups.

Read more about biosimilar pegfilgrastim.

Michael Soldan, PhD, head of the biosimilars business unit for the pharmaceuticals division of Fresenius Kabi, said in a statement, “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 life-threatening diseases, and biosimilars will be an important part of the solution.”

Fresenius Kabi acquired Merck KGaA’s biosimilars business, including the entire development pipeline of Merck’s biosimilars, in 2017. Under the terms of the acquisition, Fresenius Kabi agreed to pay Merck single-digit percentage royalties on the eventual sales of the acquired biosimilars, and upon closing the deal, Merck received €170 million (approximately $195 million) in cash, while an additional €500 million (approximately $572 million) will be distributed as milestone payments linked to achievements of development targets.

At the time the deal was announced, Fresenius Kabi said that it expected sales of its eventually approved biosimilars to begin by late 2019, and to grow to the “high triple-digit million” dollar range from 2023 onward.

Fresenius Kabi’s first biosimilar to reach the market could be its adalimumab product; in December 2017, the company announced that it had submitted a marketing authorization application for its MSB11022, referencing Humira, to the European Medicines Agency.