Pfenex And Alvogen Launch US Teriparatide
First Pfenex Launch Comes As Firm Waits For Equivalence Designation
Pfenex marketing partner Alvogen has introduced the firm’s Bonsity version of teriparatide in the US. Representing the first Pfenex-developed product to hit the market, the launch comes as the companies are still awaiting a formal equivalence designation from the FDA.
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Other expected generics include Viatris' Perforomist (formoterol fumarate), Pfizer's Sutent (sunitinib), Sanofi's Jevtana (cabazitaxel) and possibly Boehringer Ingelheim's Pradaxa.
As GDUFA III negotiations continue, FDA doesn’t seem ready to make additional changes to approval process, but industry argues guidance practices and communications need fixing and that consumers are missing out on potential savings because of it.
After launching in the US last year, the teriparatide product developed by Pfenex and Alvogen has been introduced in Europa, via commercialization partner Theramex, beginning with Germany.