Pfenex and Alvogen Report EMA’s Acceptance of MAA for PF708 (biosimilar, teriparatide)

Pfenex and Alvogen Report EMA’s Acceptance of MAA for PF708 (teriparatide, biosimilar)

Shots:

  • Pfenex and Alvogen announce that EMA has accepted MAA for its PF708, a biosimilar to Eli Lilly’s Forsteo which has generated $289M in EU & $1.6B globally in 2018 for the treatment of osteoporosis
  • is expected to receive marketing authorization in all 28 states of EU, as well as in Iceland, Liechtenstein and Norway, following to the EMA approval
  • Teriparatide (PF708) is developed by Pfenex utilizing its Pfenex Expression Technology, pursuant to the 505(b)(2) regulatory pathway in the US and will be promoted & commercialized by Theramex in Europe

Click here to read full press release/ article | Ref: GlobeNewsWire | Image: Linkedin