Sydney/Leiden, March 30, 2020 (updated November 2021) – BiosanaPharma, an Australian/Dutch biotech company, today announced the successful outcome of a comparative phase I clinical study in healthy volunteers of BP001, a biosimilar candidate to Xolair®. The study was conducted in Australia, with 84 healthy male volunteers. The results of the study show that bioavailability, safety, tolerability, and immunogenicity of BP001 are comparable to those of Xolair®.

BP001 is produced by utilizing BiosanaPharma’s innovative ‘3C process’, a fully continuous manufacturing process, cutting production costs by up to 90%. This makes BP001 the first clinical monoclonal antibody in the world to be produced with a fully continuous process, according to available market information.

This phase I study supports the further clinical development of BP001, where the next step will be a phase III study comparing BP001 to the originator in patients with allergic asthma. This study is planned to start in 2022.

Ard Tijsterman, CEO of BiosanaPharma:

 “We are very proud that we now have successful phase I results for our first biosimilar product. This validates our use of fully-continuous manufacturing for biologics and allows us to move forward in our quest to deliver low cost mAb biosimilars.”