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Pfenex submits new drug application for follow-on osteoporosis drug
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Pfenex this week submitted a new drug application to the FDA seeking approval for PF708, a follow-on biosimilar referencing teriparatide for the treatment of osteoporosis, according to a press release from the company.
PF708 is considered a therapeutic equivalent product candidate to teriparatide (Forteo, Eli Lilly) and is being developed pursuant to the 505(b)(2) regulatory pathway in the U.S.
"We are pleased to submit to the FDA an NDA for PF708 as a proposed therapeutic equivalent to Forteo, which achieved $1.7 billion in global sales in 2017," Eef Schimmelpennink, CEO of Pfenex, said in the release. "We believe the timing of the NDA submission for PF708 could allow for a potential commercial launch as early as the fourth quarter of 2019 in the U.S., subject to FDA acceptance, approval and other factors.”
The NDA submission for PF708 is based on positive data from the PF708-301 phase 3 clinical study announced earlier this year, which showed comparable overall profiles between PF708 and teriparatide after 24 weeks of daily injection in osteoporosis patients. In addition, the NDA includes data from the PF708-101 study, a single-dose, two-way crossover study comparing the pharmacokinetics of PF708 and teriparatide in healthy participants.