Pfenex Still Waiting For FDA Teriparatide Equivalence Designation
US-Based Firm Is Confident Coronavirus Will Not Impact Prospects
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.
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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.
Seven months after introducing its teriparatide biosimilar to Eli Lily’s Forsteo into many European markets, Stada is pleased with results and says doctors and patients alike have responded well.
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