---
title: "Teva Secures FDA Nod For PONLIMSI, Biosimilar Candidate To Xolair Applications Accepted By FDA & EMA"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/281030704.md"
description: "Teva Pharmaceutical Industries Limited announced FDA approval for PONLIMSI as a biosimilar to Prolia, aimed at treating bone conditions. The approval was based on comprehensive evidence showing similar efficacy and safety to Prolia. Additionally, Teva's biosimilar candidate for Xolair has been accepted by both the U.S. FDA and EMA. Yolanda Tibbe, Global Head of Biosimilars, emphasized the significance of these developments for expanding treatment options. TEVA shares are trading at $28.61, down 0.47% in pre-market hours."
datetime: "2026-03-30T13:34:03.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/281030704.md)
  - [en](https://longbridge.com/en/news/281030704.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/281030704.md)
---

# Teva Secures FDA Nod For PONLIMSI, Biosimilar Candidate To Xolair Applications Accepted By FDA & EMA

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Teva Pharmaceutical Industries Limited (TEVA), Monday announced that the U.S. Food and Drug Administration has approved PONLIMSI as a biosimilar to Prolia, to treat a variety of debilitating bone conditions.

The FDA approval was based on a totality of evidence, including analytical and clinical data demonstrating similar efficacy, safety, and immunogenicity profile as the reference product, Prolia.

Also, Teva's applications for a proposed biosimilar candidate to Xolair have been accepted by both the U.S. FDA and the European Medicines Agency.

Yolanda Tibbe, Global Head of Biosimilars at Teva, commented, "To receive U.S. FDA approval of PONLIMSI and the filing acceptances of our proposed biosimilar candidate to Xolair® in the U.S. and Europe truly underscores the strength of our expanding global biosimilar portfolio and reaffirms our commitment to expand treatment options for patients."

In the pre-market hours, TEVA is trading at $28.61, down 0.47 percent on the New York Stock Exchange.

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