Teriparatide

Pfenex Provides Update for PF708 Outside the United States

Retrieved on: 
Friday, October 11, 2019
Communication, Forward-looking statement, Teriparatide

Subject to applicable regulatory approvals, PF708 will be commercialized by PharmBio Korea in Korea, JAMP Pharma in Canada, and Kamada in Israel.

Key Points: 
  • Subject to applicable regulatory approvals, PF708 will be commercialized by PharmBio Korea in Korea, JAMP Pharma in Canada, and Kamada in Israel.
  • Pfenex will be eligible to receive milestone payments and a percentage of net sales or transfer price.
  • PF708 is approved in the U.S. under the 505(b)(2) regulatory pathway, with Forteo (teriparatide injection) as the reference drug.
  • The forward-looking statements in this press release are based on information available to Pfenex as of the date hereof, and Pfenex disclaims any obligation to update any forward-looking statements, except as required by law.

Pfenex Receives U.S. FDA Approval for PF708 to Treat Osteoporosis

Retrieved on: 
Monday, October 7, 2019
Drugs, Organ systems, RTT, Health, Osteoporosis, Food and Drug Administration, Medroxyprogesterone acetate, Bone fracture, Teriparatide

Like Forteo, the FDA-approved PF708 product is indicated for the treatment of osteoporosis in certain patients at high risk for fracture.

Key Points: 
  • Like Forteo, the FDA-approved PF708 product is indicated for the treatment of osteoporosis in certain patients at high risk for fracture.
  • Pfenex is also asking the FDA to designate PF708 as therapeutically equivalent (A rated) to Forteo, which would permit PF708 to be automatically substituted for Forteo in many states.
  • To further support an A rating, Pfenex is conducting a comparative human factors study between PF708 and Forteo as requested by FDA.
  • The U.S. approved PF708 product is indicated for the treatment of osteoporosis in certain patients at high risk for fracture.

Richter Launched Terrosa®, its Biosimilar Teriparatide Across Europe

Retrieved on: 
Tuesday, August 20, 2019
Life sciences, Biotechnology, Biosimilar, Drugs, Eli Lilly and Company, Teriparatide

("Richter") today announced that it has launched its biosimilar teriparatide, Terrosain Europe.The product is approved in adults for the same indications asEli Lilly's Forsteo, i.e.

Key Points: 
  • ("Richter") today announced that it has launched its biosimilar teriparatide, Terrosain Europe.The product is approved in adults for the same indications asEli Lilly's Forsteo, i.e.
  • Biosimilar teriparatide has been developed by Richter-Helm BioTec GmbH & Co. KG.
  • The product has been launched under the label Terrosaby Richter via its affiliates in Europe immediately following the patent expiry of the reference product in August 2019.
  • We look forward to bringing more high quality and affordable biosimilar products to the market," saidGbor Orbn, Chief Executive Officer of Richter.