The regulator approved the new drug application (NDA) for PF708, which was submitted under the 505(b)(2) regulatory pathway with Eli Lilly and Company’s Forteo as the reference medicine.
Pfenex has a development and license agreement with Alvogen under which the latter is responsible for commercialising and manufacturing PF708 in the US. Alvogen is also expected to fulfil all regulatory requirements associated with maintaining the drug’s NDA.
Pfenex is also seeking authorisation from the regulator to grant PF708 the therapeutically equivalent (“A” rated) status to Forteo. The authorisation would allow the Pfenex’s injectable drug to be substituted automatically for Forteo across several states.
The company said that to further back an “A” rating, it is carrying out a comparative human factors study between its drug and Forteo as asked by FDA.
Pfenex expects to submit the final study report to the US regulator as early as the second half of this month to assess PF708’s therapeutic equivalence to Lilly’s drug.
Pfenex CEO Eef Schimmelpennink said: “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 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.”
In February 2019, Pfenex and Alvogen expanded their collaboration to develop and commercialise the Forteo biosimilar in the European Union, certain countries in the Middle East and North Africa (MENA), and the rest of world.
In May 2019, the European Medicines Agency (EMA) accepted the marketing authorization application (MAA) submitted for PF708. In Europe, the drug is expected to be commercialised by Theramex, subject to applicable regulatory approvals.