Pfenex Inc. and Alvogen announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) submitted by its partner Alvogen for PF708 (teriparatide). The product is proposed as a therapeutic equivalent in the treatment of osteoporosis to Forteo®. The product is filed with the EMA as a biosimilar in the treatment of osteoporosis to Forsteo®, which achieved $289 million sales in the E.U. and $1.6 billion in global product sales in 2018. This acceptance means the EMA considers the MAA to be complete and initiates the EMA's formal review process. PF708 is being developed by Pfenex as a therapeutic equivalent candidate to Forteo®, which is approved and marketed by Eli Lilly and Company for the treatment of osteoporosis in certain patients with a high risk of fracture. Forteo achieved $1.6 billion in global product sales in 2018. PF708 is being developed pursuant to the 505(b)(2) regulatory pathway in the U.S. and references Forteo® as the Reference Listed Drug. PF708 has been filed with EMA using the biosimilar pathway and references Forsteo® as the Reference Drug.