The Food and Drug Administration (FDA) has approved Bonsity (teriparatide injection; Pfenex) for the treatment of osteoporosis in certain patients at high risk for fracture.
The application was approved through the Agency’s 505(b)(2) pathway; this regulatory route allows the applicant to submit information from studies conducted by a separate entity and for which the applicant has not obtained a right of reference. For Bonsity, Pfenex used Forteo (teriparatide injection; Eli Lilly) as the Reference Listed Drug.
The approval is based on data from the PF708-301 phase 3 study which showed comparable overall profiles between Bonsity and Forteo after 24 weeks of daily injection in osteoporosis patients.
The Company is currently conducting another comparative study between Bonsity and Forteo, with the aim of having the treatment designated as a therapeutic equivalent (‘A’ rated) to Forteo. They hope to submit the final results from this study to the FDA “as early as the second half of October 2019.”
“We believe [Bonsity] has the potential to significantly enhance patient access to an important therapy,” said Eef Schimmelpennink, CEO of Pfenex.
Alvogen is responsible for commercialization and manufacturing Bonsity in the US and for fulfilling all regulatory requirements associated with maintaining the Bonsity NDA.
For more information visit pfenex.com.