Pfenex And Alvogen Launch US Teriparatide
First Pfenex Launch Comes As Firm Waits For Equivalence Designation
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.
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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.
Shortly after announcing the launch of Bonsity (teriparatide) in the US, Pfenex and Alvogen have picked up positive opinions from the EMA’s CHMP for their teriparatide biosimilar. However, Accord Healthcare has withdrawn its own application following concerns raised by the agency.
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.