The US FDA and the European Medicines Agency (EMA) accepted regulatory filings for Teva Pharma’s biosimilar candidate to Xolair (omalizumab).
RT’s Three Key Takeaways:
- Regulatory Milestones: The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) accepted applications for Teva’s biosimilar candidate to Xolair, which targets allergic asthma and other IgE-mediated conditions.
- Broad Indications: The proposed biosimilar candidate covers all indications of the reference product, including persistent allergic asthma in patients 6 years and older and chronic rhinosinusitis with nasal polyps in adults.
- Clinical Data Support: The submissions are supported by a data package including analytical and clinical evidence demonstrating efficacy, safety, and immunogenicity similar to the reference biologic, according to the company.
The US FDA and the European Medicines Agency (EMA) have accepted regulatory filings for Teva Pharma’s biosimilar candidate to Xolair (omalizumab), according to the company.
The regulatory submissions consist of a Biologics License Application (BLA) to the FDA and a Marketing Authorization Application (MAA) in the European Union to the EMA. The applications include all indications approved for the reference product, which include moderate-to-severe persistent allergic asthma in patients 6 years and older and chronic rhinosinusitis with nasal polyps in adults 18 years and older.
“Our biosimilars R&D engine continues to demonstrate its depth and maturity. By combining deep internal expertise with strategic partnerships, we’re building a highly competitive portfolio,” said Steffen Nock, PhD, head of biosimilars R&D and chief science officer at Teva, in a news release.
The regulatory applications are supported by a detailed data package that includes analytical and clinical data on efficacy, safety, and immunogenicity similar to Xolair, according to the press release. Omalizumab is a humanized monoclonal antibody that targets IgE. By preventing IgE from activating the cells that cause allergic reactions, the treatment may help control or reduce symptoms in patients with chronic respiratory conditions.
In addition to the asthma candidate, Teva announced the FDA approved PONLIMSI (denosumab-adet) as a biosimilar to Prolia for the treatment of osteoporosis and to increase bone mass in patients at high risk for fracture.
“To receive US FDA approval of PONLIMSI and the filing acceptances of our proposed biosimilar candidate to Xolair in the US and Europe truly underscores the strength of our expanding global biosimilar portfolio and reaffirms our commitment to expand treatment options for patients,” said Yolanda Tibbe, global head of biosimilars at Teva, in a news release.
The biosimilar candidate for omalizumab also seeks approval for chronic spontaneous urticaria in patients 12 years and older and, in the US, IgE-mediated food allergies in patients 1 year and older. The candidate is an investigational product and has not yet received regulatory approval for healthcare use in any country.
