Pfenex Gives Teriparatide Latest After Setback
As Company Underlines Confidence In Supply Chain
Pfenex has provided an update on its bid to secure a therapeutic equivalence determination for its PF708 teriparatide product in the US, after itself and partner Alvogen were knocked back last month.
You may also be interested in...
Pfenex has less than two months for an “A” designation for therapeutic equivalence for to be granted for its Bonsity (teriparatide) 505(b)(2) product by the US FDA if it wishes to realize maximum value under the companies’ partnership agreement with Alvogen.
Pfenex marketing partner Alvogen has introduced the firm’s Bonsity version of teriparatide in the US. Representing the first Pfenex-developed product to hit the market, the launch comes as the companies are still awaiting a formal equivalence designation from the FDA.
Pfenex and partner Alvogen have suffered a setback on their PF708 teriparatide in the US, after the country’s Food and Drug Administration asked for more information to support a long-awaited designation of therapeutic equivalence to the Forteo brand.