The European Medicines Agency (EMA) has validated and accepted trastuzumab biosimilar HD201 (Tuznue?) for review the Marketing Authorization Application (MAA). The drug candidate, being developed by Singapore-based Prestige BioPharma, is a biosimilar formulation of originator biologic medicine trastuzumab (Herceptin?; Genentech/Roche).
If authorized by the EMA, HD201 would take part in the race along with Herzuma (Celltrion), Kanjinti (Amgen), Ontruzant (Merck Sharp & Dohme), and Trazimera (Pfizer) to seize the EU market as one of the comparable biosimilars, which is currently dominated by Herceptin (Roche).
Positive top-line results from the Phase I / Phase III global clinical trial of HD201 confirm that HD201 is exceptionally biosimilar to trastuzumab in terms of clinical response and pharmacokinetic (PK) equivalence, in addition to a comparable safety profile to the range previously observed in other trastuzumab biosimilar trials.
?We are very pleased that EMA has initiated the review of the HD201 Marketing Authorisation Application. It is a major step in our endeavor to become a global player focusing on biosimilars and innovative biologics,” noted Lisa S. Park, Chief Executive Officer of Prestige.
“Our development approach has proven to be highly efficient with regard to trial performance, demonstrating exceptional similarity, and dossier filing,? she added.
HD201 is Prestige?s first biosimilar to receive a positive Committee for Medicinal Products for Human Use (CHMP) opinion for marketing authorization from the EMA.
Prestige Biopharma is also expected to submit an application in the United States. To date, four trastuzumab biosimilars have been approved in the United States.
The most recently approved trastuzumab biosimilar was approved in March 2019, when the U.S. Food and Drug Administration (FDA) approved PF-05280014 (Trazimera?; also known trastuzumab-qyyp) to treat patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Based on this achievement, Prestige is expected to move forward with other 8 biosimilars and innovative biologics.
These other biosimilars include a Bevacizumab biosimilar (HD204) in Phase III, an Adalimumab biosimilar (PBP1502) in Phase I and an innovative anti-PAUF mAb (PBP1510) for the treatment of pancreatic cancer in preclinical development.
Pivot X, Deslypere JP, Park LS, Kim MJ, Lee W, Lee J. A Randomized Phase I Study Comparing the Pharmacokinetics of HD201, a Trastuzumab Biosimilar, With European Union-sourced Herceptin. Clin Ther. 2018 Mar;40(3):396-405.e4. doi: 10.1016/j.clinthera.2018.01.009. Epub 2018 Mar 2.