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TEVA's Prolia Biosimilar Gets FDA Nod, Xolair Filing Accepted
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Key Takeaways
Teva received FDA approval for Ponlimsi, a biosimilar to Amgen's Prolia for multiple bone conditions.
Teva's filing for a biosimilar to Xolair has been accepted for FDA and EMA review across all approved uses.
Teva aims to grow biosimilars by $400M by 2027, with the generics business expected to improve.
Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) announced that the FDA has approved its biosimilar to Amgen’s (AMGN - Free Report) blockbuster drug, Prolia (denosumab). The biosimilar will be available in the United States under the trade name of Ponlimsi to treat various types of debilitating bone conditions.
The FDA nod for Ponlimsi was based on overall evidence showing it has similar efficacy, safety, and immune response as AMGN’s Prolia.
Ponlimsi is approved for all uses of Prolia, including treating osteoporosis in men and postmenopausal women who are at high risk for fracture, glucocorticoid-induced osteoporosis, and improving bone mass in certain patients undergoing treatment for a certain type of prostate or breast cancer.
The biosimilar versions of Amgen’s Prolia and Xgeva were approved in the European Union in November 2025. Prolia recorded sales worth $4.4 billion in 2025. The drug accounted for 13% of Amgen’s total product sales in 2025.
We expect the approval of Ponlimsi to provide a significant boost to Teva’s biosimilar portfolio.
TEVA’s Price Performance
Year to date, shares of Teva have plunged 9.2% compared with the industry’s decline of 8.7%.
Image Source: Zacks Investment Research
Filing for TEVA’s Biosimilar to Xolair Accepted for Review
Teva also announced that the FDA and the EMA have accepted the biologics license application (BLA) and the marketing authorization application (MAA), respectively, for its proposed biosimilar candidate to Novartis’ (NVS - Free Report) Xolair (omalizumab).
Both the BLA and the MAA include all approved indications for NVS’ Xolair in the United States and EU, i.e., moderate-to-severe, persistent allergic asthma in patients aged six and above, chronic rhinosinusitis with nasal polyps in adults, chronic spontaneous urticaria in patients aged 12 and older. In the United States, it also includes IgE-mediated food allergies in patients aged one and above.
These applications are backed by a comprehensive data package showing similar efficacy, safety, and immune response as Xolair. Novartis recorded $1.7 billion in Xolair sales in 2025.
Teva has a decent pipeline of biosimilars. The company’s U.S. generics/biosimilars business looks stable now, despite headwinds, much more than it has been in years. Teva’s global generics business was flat in 2025 from 2024 levels. However, Teva expects its global generics business to improve going forward, driven by complex generic launches in the United States, several generic launches in ex-U.S. markets, and new biosimilar launches.
In 2026, Teva expects its global generics business to rise in a low single-digit range. The company aims to grow its biosimilars business by $400 million by 2027.
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TEVA's Prolia Biosimilar Gets FDA Nod, Xolair Filing Accepted
Key Takeaways
Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) announced that the FDA has approved its biosimilar to Amgen’s (AMGN - Free Report) blockbuster drug, Prolia (denosumab). The biosimilar will be available in the United States under the trade name of Ponlimsi to treat various types of debilitating bone conditions.
The FDA nod for Ponlimsi was based on overall evidence showing it has similar efficacy, safety, and immune response as AMGN’s Prolia.
Ponlimsi is approved for all uses of Prolia, including treating osteoporosis in men and postmenopausal women who are at high risk for fracture, glucocorticoid-induced osteoporosis, and improving bone mass in certain patients undergoing treatment for a certain type of prostate or breast cancer.
The biosimilar versions of Amgen’s Prolia and Xgeva were approved in the European Union in November 2025. Prolia recorded sales worth $4.4 billion in 2025. The drug accounted for 13% of Amgen’s total product sales in 2025.
We expect the approval of Ponlimsi to provide a significant boost to Teva’s biosimilar portfolio.
TEVA’s Price Performance
Year to date, shares of Teva have plunged 9.2% compared with the industry’s decline of 8.7%.
Image Source: Zacks Investment Research
Filing for TEVA’s Biosimilar to Xolair Accepted for Review
Teva also announced that the FDA and the EMA have accepted the biologics license application (BLA) and the marketing authorization application (MAA), respectively, for its proposed biosimilar candidate to Novartis’ (NVS - Free Report) Xolair (omalizumab).
Both the BLA and the MAA include all approved indications for NVS’ Xolair in the United States and EU, i.e., moderate-to-severe, persistent allergic asthma in patients aged six and above, chronic rhinosinusitis with nasal polyps in adults, chronic spontaneous urticaria in patients aged 12 and older. In the United States, it also includes IgE-mediated food allergies in patients aged one and above.
These applications are backed by a comprehensive data package showing similar efficacy, safety, and immune response as Xolair. Novartis recorded $1.7 billion in Xolair sales in 2025.
Teva has a decent pipeline of biosimilars. The company’s U.S. generics/biosimilars business looks stable now, despite headwinds, much more than it has been in years. Teva’s global generics business was flat in 2025 from 2024 levels. However, Teva expects its global generics business to improve going forward, driven by complex generic launches in the United States, several generic launches in ex-U.S. markets, and new biosimilar launches.
In 2026, Teva expects its global generics business to rise in a low single-digit range. The company aims to grow its biosimilars business by $400 million by 2027.
TEVA’s Zacks Rank
Teva currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.