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

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.
 
The Center for Biosimilars Staff
July 26, 2018
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.

The phase 1 study enrolled 168 healthy volunteers who were randomized to receive either a single 150-mg dose of GBR 310 or a single 150-mg dose of the US-licensed reference omalizumab, which is marketed jointly by Genentech and Novartis.

Omalizumab is FDA approved to treat asthma in patients whose symptoms are not well controlled by other therapies. While most patients with asthma are able to control their disease with long-acting beta agonists, inhaled steroids, and rescue inhalers, 5% to 15% of patients with asthma have severe disease, and turn to injected biologics, such as omalizumab, to reduce airway inflammation. The drug is also approved to treat chronic idiopathic urticaria, or hives without a known cause, in patients whose symptoms are not controlled by antihistamine treatment.

“We are pleased with the rapid progress made in the development of GBR 310, and look forward to meeting with the FDA this fall with the goal of advancing this proposed biosimilar candidate,” said Kurt Stoeckli, president and chief scientific officer at Glenmark Pharmaceuticals, in announcing the results.

Another biosimilar developer has also revealed positive clinical study data for a proposed biosimilar, though it has not yet announced filing of a Biologics License Application with the FDA; in 2016, Sorrento Therapeutics, Inc, together with partner Mabtech, completed a combined phase 2 and phase 3 trial of STI-004 in China.

The proposed biosimilar met its primary endpoint in the multicenter, randomized, double-blind, placebo-controlled trial; in the 32-week study, only 21% of the patients receiving the proposed biosimilar experienced an asthma exacerbation (versus 55% of the placebo group), and those who took STI-004 also were also able to reduce their dosages of steroids and rescue drugs. The types and incidence rates of adverse events observed with STI-004 were similar to those seen with the reference drug.

A key patent for the reference biologic is slated to expire in 2018, and if a biosimilar does come to the US market, it could compete with the reference product for a share of $2.0 billion in annual sales.
 

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