Pfenex gets FDA nod for potential Forteo generic
Pfenex has received the Food and Drug Administration’s blessing for PF708.
The product uses Forteo (teriparatide injection) as a reference drug, and like Forteo is indicated for the treatment of osteoporosis in certain patients at high risk for fracture.
“The FDA’s approval of PF708 marks a major milestone in Pfenex’s history as our first approved commercial product and further validates our Pfēnex Expression Technology platform. We look forward to continuing to work with our commercialization partner Alvogen to launch PF708 in the United States. We believe PF708 has the potential to significantly enhance patient access to an important therapy as a cost-effective alternative to Forteo, which had $1.6 billion in global sales in 2018,” Pfenex CEO Eef Schimmelpennink said.
The company now is asking the FDA to designate PF708 as therapeutically equivalent to Forteo, which would allow the product to be automatically substituted for Forteo in many states. The company said it is working to submit a final comparative human factors study to the FDA by the latter half of the month.
"Looking ahead, we are confident in the planning that Alvogen has done thus far in preparation for the commercial launch of PF708 and their established sales and marketing teams are excited to bring PF708 to market," Schimmelpennink said, noting that he expects Alvogen to launch PF708 once the FDA makes a decision on therapeutic equivalence.