Eye on Pharma: Pfenex and Alvogen Submit Application for PF708 to EMA

Pfenex and its partner Alvogen have submitted to the European Medicines Agency (EMA) a Marketing Authorization Application (MAA) for PF708, which is a proposed biosimilar of teriparatide (Forteo), an osteoporosis drug.

“The acceptance of the PF708 MAA filing is an important milestone for Pfenex and Alvogen and demonstrates that through our collaborative partnership, we continue making progress towards potential approvals beyond the United States,” said Eef Schimmelpennink, chief executive officer of Pfenex, in a statement. “Subject to applicable regulatory approvals, for Europe, PF708 will be commercialized by Theramex, a leading global specialty pharmaceutical company dedicated to women’s health.”

Pfenex is also awaiting regulatory approval for the same product in the United states, where it submitted an application to the FDA for consideration in December 2018. Whereas in the European Union, subsequent-entry versions of teriparatide are regulated as biosimilars, in the United States, they are treated as follow-on products. As such, Pfenex has submitted a 505(b)(2) New Drug Application (NDA) rather than an abbreviated Biologics License Application for the product.

Although many products treated as drugs by the FDA (like insulins and hormones) will be regulated as biologics beginning on March 23, 2020, teriparatide is not on the FDA’s preliminary list of products that will make that transition. Thus, the product is expected to remain a follow-on in the US context.

Pfenex has indicated that it expects to be able to launch PF708 in the United States as early as the fourth quarter of 2019, where it could begin competing for the reference product’s estimated $1.6 billion in annual global product sales.