Alvogen and Pfenex’s PF708 (biosimilar, teriparatide) Receives FDA’s Approval for the Treatment of Osteoporosis

Alvogen and Pfenex’ PF708 (biosimilar, teriparatide) Receives FDA’s Approval for the Treatment of Osteoporosis

Shots:

  • The US FDA has granted approval to PF708, a biosimilar of Eli Lilly’s Forteo (teriparatide injection) under the 505(b)(2) regulatory pathway for the treatment of osteoporosis in certain patients at high risk for fracture
  • Pfenex will receive a $2.5M milestone from Alvogen on its approval in the US. The PF708 is the first approved product of Pfenex, validating Pfenex Expression Technology platform and enhances patient’s access to a cost-effective alternative to Forteo
  • Pfenex is conducting a comparative human factors study between PF708 and Forteo, evaluating the therapeutic equivalence of both the therapies with its anticipated submission by the end of Oct’19

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Pfenex