Posted by Michael Wonder on 31 May 2019
Pfenex and Alvogen announce European Medicines Agency accepts marketing authorisation application for PF708
30 May 2019 - Pfenex and Alvogen today announced that the EMA has accepted the marketing authorisation application submitted by our 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 application to be complete and initiates the EMA's formal review process.
