Cinfa shows biosimilar equivalence

A biosimilar version of pegfilgrastim – the pegylated granulocyte colony-stimulating factor (G-CSF) – demonstrated pharmacokinetic and pharmacodynamic equivalence with the original in a trial. Biosimilars company Cinfa Biotech S.L., headquartered in Pamplona, Spain, announced the results of their single-dose, randomised, double-blind, cross-over study with 172 healthy volunteers in Germany. 

Cinfa’s biosimilar B12019 also showed safety and immunogenicity. Further data from the trial will be presented at upcoming scientific conferences, said Ruediger Jankowsky, Managing Director of Cinfa Biotech: “We are pleased to have achieved this significant milestone in the development of our first biosimilar candidate B12019.” Cinfa now plans to accelerate the establishment of partnerships for commercialisation, he adds: “We expect a timely submission for approval in Europe."

Earlier this year, the European Medicines Agency (EMA) already announced the market approval of Sandoz’ biosimilar version of pegfilgrastim. The patent for the original product (Neulasta) has been one of the most important revenue-drivers of the US-biotech company Amgen. The 175 amino acid protein is produced in E. coli bacteria transfected with the G-CSF gene. Additional biosimilars of pegfilgrastim are marketed by Sicor Biotech, Hospira und Intas Pharmaceuticals.

Currently, Pegfilgrastim is indicated to treat chemotherapy-induced neutropenia, a life-threatening shortage of white blood cells (neutrophils), which are crucial to fight off infections. Whereas filgrastim has a half-life in humans of about four hours, the attachment of polyethylene glycol (PEG) prolongs its lifetime to 15 to 80 hours, in which it could stimulate the bone marrow’s production of neutrophils to decrease the incidence of infections in patients undergoing chemotherapy.

B12019 is Cinfa Biotech’s most advanced biosimilar. The company belongs to Infarco group and has offices in Munich, too. Cinfa intends to build a pipeline of biosimilar drugs “for a range of indications to address the growing need for affordable therapies.”

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