Spanish biosimilars company Cinfa Biotech has reported positive top-line clinical trial results of B12019, a biosimilar version of Neulasta (pegfilgrastim), to treat chemotherapy-induced neutropenia.

The single-dose, randomised, double-blind, cross-over trial involved 172 healthy volunteers in Germany.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

The trial was primarily focused to determine the pharmacokinetic (PK) and pharmacodynamic (PD) profile of B12019 when compared with Neulasta.

The secondary endpoint of the trial was to evaluate the safety and immunogenicity of B12019.

"We are pleased to have achieved this significant milestone in the development of our first biosimilar candidate B12019."

Both B12019 and Neulasta have displayed safety, tolerability and immunogenicity.

See Also:

Cinfa Biotech managing director Dr Ruediger Jankowsky said: "We are pleased to have achieved this significant milestone in the development of our first biosimilar candidate B12019.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

"All endpoints of the clinical trial have been met, confirming the high quality of our product candidate. These positive results confirm our development strategy, which is based on most up-to-date scientific considerations and includes a second clinical study to investigate the immunogenicity of B12019.

"We will now accelerate the establishment of partnerships for commercialisation as we expect a timely submission for approval in Europe."

Pegfilgrastim is developed to treat chemotherapy-induced neutropenia.

It consists of the pegylated granulocyte colony-stimulating factor (G-CSF) receptor agonist, which stimulates bone marrow to produce more neutrophils to decrease the incidence of infections in patients undergoing chemotherapy.