Alvogen And Pfenex Have Teriparatide Filing Accepted By EMA
The EMA has formally accepted for filing Alvogen and Pfenex’ centralized marketing authorization application for a biosimilar rival to Lilly’s Forsteo teriparatide blockbuster.
You may also be interested in...
Alvogen has signed marketing deals with local firms in Canada, Israel and South Korea for the teriparatide drug it has licensed from Pfenex. In the US, Pfenex has just completed a human factors study it feels should support a therapeutic equivalence rating for its Forteo rival.
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.
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.