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.
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.
HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending Remain
November 28th 2023Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
Biosimilar Business Roundup for October 2023—Podcast Edition
November 5th 2023On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.
Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar
November 22nd 2023Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).
Biosimilars Business Roundup For August 2023—Podcast Edition
September 5th 2023On this episode, we’re giving an overview of some of the biggest stories in the business space regarding biosimilars, like the approval of the first neurology biosimilar, growth projections from company quarterly expense reports, and some analyses about the health of the market.
AMCP Nexus: Panelists Share Current Scope of Biosimilar Industry
October 26th 2023Panelists at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting chronicled the current state of the US biosimilar market, including current policies impacting the market, recent regulatory decisions, and the developing arguments around requirements for clinical efficacy studies.
Report: Conflicting Guidelines, Rebate Walls Are Major Factors Determining Biosimilar Uptake
October 24th 2023Samsung Bioepis’ most recent biosimilar market report identified inconsistent medical guidelines, challenges with access and rebates, and acute vs chronic treatment duration as major factors influencing biosimilar uptake in the United States.