Teva Secures FDA Approval for PONLIMSI, FDA and EMA Accept Omalizumab Biosimilar Filings
The FDA approved Teva’s PONLIMSI (denosumab-adet) biosimilar for all reference Prolia indications, including osteoporosis and cancer-related bone loss. Teva also obtained FDA and EMA acceptance of its omalizumab biosimilar BLA and MAA filings, reinforcing its Pivot to Growth strategy and expanding its global biosimilars portfolio.
1. FDA Approval of PONLIMSI
The FDA granted approval for PONLIMSI (denosumab-adet) as a biosimilar to Prolia, covering all indications from postmenopausal osteoporosis to bone-mass increases in cancer patients. Approval was based on comprehensive analytical and clinical data demonstrating equivalent efficacy, safety and immunogenicity to the reference product.
2. Omalizumab Biosimilar Filing Acceptances
Teva’s Biologics License Application for its proposed Xolair (omalizumab) biosimilar has been accepted by the FDA, with a parallel Marketing Authorization Application accepted by the EMA. Both submissions encompass all reference indications, spanning asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and IgE-mediated food allergies.
3. Strategic Implications for Teva
These regulatory milestones underscore progress in Teva’s Pivot to Growth strategy by bolstering its position in the biosimilars market. The dual approvals and filings broaden Teva’s product pipeline, potentially driving revenue diversification and strengthening its competitive stance against originator biologics.