Positive phase III results for trastuzumab biosimilar HD201

Biosimilars/Research | Posted 26/07/2019 post-comment0 Post your comment

Singapore-based Prestige BioPharma (Prestige) announced on 24 June 2019 positive phase III data for its trastuzumab biosimilar, HD201. The results, according to Prestige, ‘confirm the similarities between HD201 and trastuzumab’.


The phase III global, randomized, double-blind, parallel-arm, equivalence trial (Troika: NCT03013504) was designed to compare the efficacy, safety, and pharmacokinetics of HD201 to Herceptin (originator trastuzumab) in patients with human epidermal growth factor receptor 2 positive (HER2+) early breast cancer (EBC) and enrolled 502 patients. Patients were randomized (1:1) to receive either HD201 or Herceptin in combination with chemotherapy. HD201 or Herceptin was administered every 3 weeks for 8 cycles (24 weeks). After administration of the final neoadjuvant study drug dose, surgery was performed within 3−8 weeks followed by an adjuvant treatment period for 10 cycles.

The primary efficacy endpoint of the study was total pathological complete response (tpCR) whereas the secondary endpoints were breast pCR, pCR without ductal carcinoma in situ (DCIS), overall response (ORR), breast conservation rate, disease- free survival (DFS), progression-free survival (PFS), overall survival (OS), pharmacokinetics (PK), pharmacodynamics (PD), and biomarkers and safety.

These results, according to Dr Lisa S Park, CEO of Prestige BioPharma, ‘demonstrate that HD201 is the most equivalent biosimilar of Herceptin’. She added that ‘Troika has broken many records - fastest recruitment, lowest screening failure and drop-out, most exceptional similarity, and the fastest dossier generation and filing’.

These data were used to support the submission of HD201 to the European Medicines Agency in May 2019 [1].

Prestige says that it will present the 24-week data from this study at the European Society for Medical Oncology Congress 2019, which will be held on 31 September–1 October 2019 in Barcelona, Spain.

Related article
Biosimilars of trastuzumab

1. GaBI Online - Generics and Biosimilars Initiative. Trastuzumab biosimilar from Prestige accepted for review by EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jul 26]. Available from: www.gabionline.net/Biosimilars/News/Trastuzumab-biosimilar-from-Prestige-accepted-for-review-by-EMA 

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.

Source: Prestige BioPharma

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010