BiosanaPharma to Start Phase 1 Trial of Biosimilar Omalizumab in Australia

Biosana Pty Ltd, a subsidiary of BiosanaPharma BV, says it received permission from the Australian Bellberry Human Research Ethics Committee (HREC) to start a phase 1 trial for a biosimilar version of omalizumab.

The trial consists of a bioequivalence, double-blind, randomized, 2 parallel-group study of the firm’s humanized anti-immunoglobulin E monoclonal antibody BP001 as lyophilized powder formulation compared with the reference product (Xolair) in healthy male volunteers. Results are expected in the fourth quarter of this year.

Before seeking approval from the HREC for the trial, an extensive comparability exercise was performed between BP001 and the reference Xolair, which is marketed by Novartis. Comparability exercises indicated functional, binding, and structural similarity between the 2 molecules, and the laboratory exercise was also enough for Biosana to obtain a waiver for preclinical studies in animal models from the European Medicines Agency, the company says.

Ard Tijsterman, MSc, the chief executive officer of BiosanaPharma, says the company is “happy and proud” to begin trials of its first biosimilar product and will start talks with potential marketing and sales partners for phase 3 trials.

Novartis’ omalizumab lost its primary patent protection in the United States in June 2017, and in Europe in August 2017.

At least 2 other biosimilars are currently in development: GBR 310 from Glenmark Pharmaceuticals, and STI-004 from Sorrento Therapeutics, Inc, in collaboration with Mabtech.

STI-004 is the farthest along, having completed a combined phase 2 and phase 3 trial in China in 2016. Though the developers have not yet announced a filing of a Biologics License Application with the FDA, the potential biosimilar met its primary end point in the multicenter, randomized, double-blind, placebo-controlled trial.

A phase 1 study of GBR 310 revealed similar pharmacokinetic, pharmacodynamic, safety, and immunogenicity profiles to reference omalizumab.

Novartis, for its part, is fighting back against encroaching challengers in this therapeutic space. In October, the FDA granted approval for a pre-filled syringe formulation of the reference product. Additionally, Novartis is looking to expand omalizumab’s indications, as it recently earned FDA’s breakthrough therapy designation in August 2018 as a treatment for food allergies. In 2017, omalizumab brought in $1.75 billion in the United States alone.