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Teva获得安进Prolia生物仿制药批准

2026-03-30 23:01

The US FDA has approved Teva Pharmaceutical Industries' (TEVA) Ponlimsi (denosumab-adet), a biosimilar to Amgen's (AMGN) osteoporosis drug Prolia (denosumab).
Prolia is Amgen's best-selling therapy, bringing in ~$4.4B in revenue in 2025.
Teva also said that the FDA and the European Medicines Agency have agreed to review its biosimilar applications for Genentech (RHHBY) and Novartis' (NVS) Xolair (omalizumab), which is used to treat conditions including asthma and chronic rhinosinusitis with nasal polyps.
In 2025, Roche, Genentech's parent company, reported ~$3.8B in Xolair sales, while Novartis reported its share as $~1.7B.

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Teva Pharmaceutical Industries Limited (TEVA) Presents at Barclays 28th Annual Global Healthcare Conference Transcript
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FDA issues draft guidance to relax testing rules to encourage biosimilar drugs

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