Pfenex And Alvogen Suffer Teriparatide Setback
FDA Asks For More Data Before It Can Grant Equivalence
Pfenex and partner Alvogen have suffered a setback on their PF708 teriparatide in the US, after the country’s Food and Drug Administration asked for more information to support a long-awaited designation of therapeutic equivalence to the Forteo brand.
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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.
Pfenex has provided an update on its bid to secure a therapeutic equivalence determination for its PF708 teriparatide product in the US, after itself and partner Alvogen were knocked back last month.
Hailing the past year as a "transformational period" in which "we moved towards being a business with an FDA-approved product nearing commercialization," Pfenex ended 2019 in profit and with cash in the bank, as it eyes the potential for a monopoly in the follow-on teriparatide market.