Respiratory

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