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Alvogen And Pfenex Have Teriparatide Filing Accepted By EMA

Executive Summary

The EMA has formally accepted for filing Alvogen and Pfenex’ centralized marketing authorization application for a biosimilar rival to Lilly’s Forsteo teriparatide blockbuster.

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Alvogen Strikes Deals For Pfenex’ Teriparatide

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 Gets US Teriparatide Nod

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 And Alvogen May Face Delay In Teriparatide Equivalence Rating

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