Respiratory

Celltrion Healthcare Advances Trials for Omalizumab Biosimilar

October 9th 2020

By Tony Hagen

The product would target the lucrative, billion-dollar worldwide market for Xolair.

BiosanaPharma Reports Positive Phase 1 Results for Omalizumab Biosimilar

April 9th 2020

By Tony Hagen

With positive phase 1 study results and a manufacturing process that may cut costs significantly, BiosanaPharma hopes its omalizumab biosimilar candidate will have an edge on the worldwide market.

Celltrion to Start Phase 1 Trial of Omalizumab Biosimilar, CT-P39

July 16th 2019

By Kelly Davio

Republic of Korea–based drug maker Celltrion announced this week that it is launching its first clinical trial of CT-P39, a proposed biosimilar omalizumab referencing Xolair. The company says that it plans to enter phase 3 trials in the first half of 2020 and has plans to commercialize the biosimilar by 2022.

BiosanaPharma to Start Phase 1 Trial of Biosimilar Omalizumab in Australia

April 5th 2019

By Allison Inserro

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.

Novartis Prepares to Defend Omalizumab Market as Potential Biosimilars Advance

December 10th 2018

By Samantha DiGrande

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.

Eye on Pharma: Positive Phase 1 Data for Glenmark's Omalizumab Biosimilar

July 26th 2018

By The Center for Biosimilars Staff

A little over a year after having received FDA authorization to commence its clinical program, Glenmark Pharmaceuticals has announced that its phase 1 study of GBR 310 revealed similar pharmacokinetic, pharmacodynamic, safety, and immunogenicity profiles between its proposed omalizumab biosimilar and the reference product, Xolair.

Omalizumab Biologic is Changing the Face of Asthma Therapeutics

March 20th 2017

By The Center for Biosimilars Staff