Pfenex Inc. said the European Medicines Agency accepted a marketing authorization application for a biosimilar of Eli Lilly and Co.'s osteoporosis drug Forteo.
Lilly raised $1.60 billion from global sales of Forteo and $289 million in the EU in 2018, according to a May 30 press release from Pfenex.
Pfenex's partner Alvogen Inc. submitted the application to the EMA for PF708, or teriparatide, to treat osteoporosis. The disease causes the bones to become weak and brittle, and mild stresses such as bending over and coughing can cause a fracture.
Alvogen is a private pharmaceuticals company that develops generic, branded, over-the-counter and biosimilar products for patients worldwide.
Pfenex CEO Eef Schimmelpennink said PF708 will be commercialized in Europe by private pharmaceutical company Theramex, subject to regulatory approvals.
San Diego-based Pfenex is a clinical-stage biotechnology company that develops protein therapies for unmet patient needs.