FDA News

FDA approves osteoporosis follow-on biologic

The FDA on Monday approved an osteoporosis medication — PF708 — developed by Pfenex under the 505(b)(2) regulatory pathway as a follow-on biologic to teriparatide injection, according to a press release from the company.

PF708 is indicated for treatment of osteoporosis among patients with high risk for fracture. When compared with its reference medication, teriparatide injection (Forteo, Eli Lilly), PF708 has the same amino-acid sequence.

“The FDA’s approval of PF708 marks a major milestone in Pfenex’s history as our first approved commercial product and further validates our Pfnex Expression Technology platform,” Eef Schimmelpennink, CEO of Pfenex, said in the release. “We look forward to continuing to work with our commercialization partner Alvogen to launch PF708 in the U.S. 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.”

According to the release, in addition to this approval, the FDA is considering Pfenex’s request for an “A” rated therapeutically equivalent designation for PF708. This “would permit PF708 to be automatically substituted for Forteo in many states,” according to the release. The decision will hinge on the results of a comparative human factors study, which Pfenex said may be available later this 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 in the release. “To optimize patient and payer impact, we currently expect our commercial partner Alvogen to launch PF708 upon an FDA decision on the therapeutic equivalence rating.”

The European Medicines Agency approved PF708 as a Forteo biosimilar earlier this year.

Disclosure: Schimmelpennink reports he is CEO of Pfenex.

The FDA on Monday approved an osteoporosis medication — PF708 — developed by Pfenex under the 505(b)(2) regulatory pathway as a follow-on biologic to teriparatide injection, according to a press release from the company.

PF708 is indicated for treatment of osteoporosis among patients with high risk for fracture. When compared with its reference medication, teriparatide injection (Forteo, Eli Lilly), PF708 has the same amino-acid sequence.

“The FDA’s approval of PF708 marks a major milestone in Pfenex’s history as our first approved commercial product and further validates our Pfnex Expression Technology platform,” Eef Schimmelpennink, CEO of Pfenex, said in the release. “We look forward to continuing to work with our commercialization partner Alvogen to launch PF708 in the U.S. 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.”

According to the release, in addition to this approval, the FDA is considering Pfenex’s request for an “A” rated therapeutically equivalent designation for PF708. This “would permit PF708 to be automatically substituted for Forteo in many states,” according to the release. The decision will hinge on the results of a comparative human factors study, which Pfenex said may be available later this 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 in the release. “To optimize patient and payer impact, we currently expect our commercial partner Alvogen to launch PF708 upon an FDA decision on the therapeutic equivalence rating.”

The European Medicines Agency approved PF708 as a Forteo biosimilar earlier this year.

Disclosure: Schimmelpennink reports he is CEO of Pfenex.