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.
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.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.