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Pfenex Eyes Teriparatide Launch Late Next Year As It Submits FDA Application

 
• By Dean Rudge

Having moved recently its projected launch date for its follow-on teriparatide proudct, US-based Pfenex has settled on the fourth quarter of next year for potential market entry, with a commercialisation partner secured and a legal strategy at hand.

Filing
Pfenex has submitted PF708 for filing with the FDA • Source: Shutterstock

Pfenex is maintaining a potential US launch date for the company’s PF708 follow-on alternative to Eli Lilly’s Forteo (teriparatide) “as early as” the fourth quarter of next year, after submitting its hybrid 505(b)(2) new drug application (NDA) with the US Food and Drug Administration (FDA).

The FDA’s review of the osteoporosis drug is expected to take around 10 months, Pfenex believes.

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