Pfenex Gets US Teriparatide Nod
Partner Alvogen is expected to launch the Forteo rival upon an FDA equivalence decision
Pfenex’ PF708 version of Forteo, submitted under the US 505(b)(2) hybrid regulatory pathway, has been approved by the FDA. Marketing partner Alvogen is expected to launch as soon as the FDA decides on the product’s equivalence rating after Pfenex submits a key study.
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Israel’s Kamada has struck a licensing deal with Alvotech that gives it rights to several of the firm’s biosimilars in its domestic market. The first launch, of the teriparatide biosimilar co-developed with Pfenex, is planned for 2022.
The latest drug development news and highlights from our US FDA Performance Tracker.
Pfenex remains hopeful of receiving US approval for its teriparatide hybrid rival to Eli Lilly’s Forteo in October this year. But commercial partner Alvogen may have to wait for a therapeutic equivalence rating to the osteoporosis original.