A Phase 1, Double-Blind, Randomised, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and Herceptin in Healthy Male Subjects

Start Date29 Apr 2019

Sponsor / Collaborator-

NCT03776240

/ CompletedPhase 1

A Phase I, Double-Blind, Randomised, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male Subjects

The purpose of the study is to demonstrate demonstrate the pharmacokinetic (PK) similarity of HD201 to the European (EU) and American (US) reference products Herceptin, following a single i.v. infusion of 6 mg/kg in healthy volunteers.

Start Date01 Apr 2019

Sponsor / Collaborator

Prestige BioPharma Ltd.

NCT03013504

/ CompletedPhase 3

A Randomised, Double-blind, Parallel Group, Equivalence, Multicentre Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in Patients with HER2+ Early Breast Cancer

In the TROIKA study, the proposed biosimilar HD201 will be compared to its reference product Herceptin®. The aim of the study is to demonstrate equivalence of HD201 and Herceptin® in terms of efficacy, safety and pharmacokinetics.

Start Date19 Feb 2018

Sponsor / Collaborator

Prestige BioPharma Ltd.

100 Clinical Results associated with Trastuzumab Biosimilar (Prestige BioPharma)

100 Translational Medicine associated with Trastuzumab Biosimilar (Prestige BioPharma)

100 Patents (Medical) associated with Trastuzumab Biosimilar (Prestige BioPharma)

Literatures (Medical) associated with Trastuzumab Biosimilar (Prestige BioPharma)

01 Mar 2025·DRUGS IN R&D

Comparative Preclinical Evaluation of Tuznue Versus Referent Herceptin: A Registered Trastuzumab Biosimilar

Article

Author: Bischoff, Herve ; Majeed, Fathima ; Park, Lisa S ; Bigot, Cecile ; Kim, Jamie ; Chakraborty, Rusha ; Boudali, Lotfi ; Pradhan, Sumita ; O'Connor, Neil K ; Coliat, Pierre ; Popescu, Bogdan V ; Pivot, Xavier ; Detappe, Alexandre ; Jaison, Litha

INTRODUCTION:

The high cost of trastuzumab (Herceptin^®) limits its accessibility for patients worldwide. Biosimilars, such as Tuznue^® (HD201), represent a promising alternative to improve access to this essential therapy for HER2-positive breast cancer. This study aims to assess the similarity of Tuznue^® with the reference product Herceptin^® through comprehensive analytical and biofunctional evaluations, ensuring similar quality, safety, and efficacy profiles.

METHODS:

Multiple analytical methods were performed to assess key quality attributes of Tuznue^® and Herceptin^®. Physicochemical properties, HER2 binding, anti-proliferative activity, antibody-dependent cellular cytotoxicity, complement dependent cytotoxicity, and Fc receptor binding were evaluated through various bioassays. Statistical analyses were conducted according to a risk-based tiered approach (Tiers 1-3) to demonstrate biosimilarity. The equivalence margin for critical quality attributes (Tier 1) was set at ±1.5 standard deviations from the reference product's mean.

RESULTS:

Tuznue^® showed highly comparable results to Herceptin^® across all evaluated biofunctional assays. HER2 binding affinity, inhibition of cellular proliferation, and antibody-dependent cellular cytotoxicity activity were equivalent between Tuznue^® and Herceptin^®, with 90% confidence intervals within predefined equivalence margins. No complement dependent cytotoxicity activity was observed for either product. Differences in glycosylation profiles were identified but did not affect critical biofunctional properties. Fc receptor binding remained consistent across all tested lots.

CONCLUSIONS:

The comprehensive analytical characterization confirms the biosimilarity of Tuznue^® to Herceptin^®. This supports Tuznue^® as a safe and effective alternative, offering a more affordable option for patients and healthcare systems. Biosimilar development requires overcoming inherent challenges, particularly when reference products exhibit variability in quality attributes over time. Regulatory guidance and scientific rigor are essential to ensuring biosimilar similarity, facilitating broader patient access to life-saving therapies.

01 May 2022·JAMA oncologyQ1 · MEDICINE

Efficacy of HD201 vs Referent Trastuzumab in Patients With ERBB2-Positive Breast Cancer Treated in the Neoadjuvant Setting

Q1 · MEDICINE

Article

Author: Soo Hoo, Hwoei Fen ; Petrelli, Fausto ; Georgievich, M. A. ; Kim, Jamie ; Jaison, Litha ; Dzagnidze, Giorgi ; Kaewkangsadan, Viriya ; Nikolaevich, Lipatov O. ; Deforce, Filip ; Cox, David G. ; Derde, Marie-Paule ; Shamrai, Volodymyr ; Kaufman, Leonard ; Villanueva, Cristian ; Pivot, Xavier ; Bonamy, Ghislain M. C. ; Hii, Jocelyn ; Pradhan, Sumita ; Feyaerts, Peggy

Importance:

The drug HD201 is a biosimilar candidate for breast cancer treatment as the reference trastuzumab.

Objective:

To compare the efficacy of HD201 with referent trastuzumab.

Design, Setting, and Participants:

This randomized clinical trial (TROIKA) included 502 women with ERBB2-positive early breast cancer treated with either HD201 or referent trastuzumab. It was conducted across 70 centers in 12 countries, including Western and Eastern Europe and Asian countries. Randomization was stratified by tumor hormone receptor status, clinical stage, and geographic region of recruitment. This analysis was conducted on February 12, 2021, after the completion of the adjuvant phase at a median of 31 months (IQR, 28-33 months) of follow-up.

Interventions:

Patients with ERBB2-positive early breast cancer were randomly assigned to receive HD201 or referent trastuzumab in the neoadjuvant setting for 8 cycles, concurrently with 4 cycles of docetaxel, which was followed by 4 cycles of epirubicin and cyclophosphamide. Patients then underwent surgery, which was followed by treatment with 10 cycles of adjuvant HD201 or referent trastuzumab.

Main Outcome and Measures:

The primary end point was the total pathological complete response (tpCR) assessed after neoadjuvant treatment. Equivalence was concluded if the 95% CI of the absolute difference in tpCR between arms in the per-protocol set was within the margin of more or less than 15%. Other objectives included the breast pathological complete response, overall response, event-free and overall survival, safety, pharmacokinetics, and immunogenicity.

Results:

A total of 502 female patients (mean [range] age, 53 [26-82] years) were randomized to receive either HD201 or referent trastuzumab, and 474 (94.2%) were eligible for inclusion in the per-protocol set. The baseline characteristics were well balanced between the 2 arms; 195 tumors (38.8%) were hormone receptor-negative , and 213 patients (42.4%) had clinical stage III disease. The tpCR rates were 45% and 48.7% for HD201 and referent trastuzumab, respectively. The difference between the 2 groups was not significant at -3.8% (95% CI, -12.8% to 5.4%) and fell within the predefined equivalence margins. The ratio of the tpCR rates between the 2 arms was 0.92 (95% CI, 0.76 to 1.12). A total of 433 patients (86.1%) presented with 2232 treatment-emergent adverse events of special interest for trastuzumab during the entire treatment period, with 220 (88.0%) and 213 (84.5%) patients in the HD201 and referent trastuzumab groups, respectively.

Conclusions and Relevance:

The results of this randomized clinical trial found that HD201 demonstrated equivalence to referent trastuzumab in terms of efficacy for the end point of tpCR, with a similar safety profile.

Trial Registration:

ClinicalTrials.gov Identifier: NCT03013504.

01 Mar 2018·Clinical therapeuticsQ4 · MEDICINE

A Randomized Phase I Study Comparing the Pharmacokinetics of HD201, a Trastuzumab Biosimilar, With European Union–sourced Herceptin

Q4 · MEDICINE

Article

Author: Pivot, Xavier ; Park, Lisa Soyeon ; Deslypere, Jean Paul ; Kim, Michael Jinwoo ; Lee, Wonjae ; Lee, Jeonghyeon

PURPOSE:

This first-in-human study of HD201 was designed to evaluate the pharmacokinetic (PK) equivalence between this biosimilar candidate and trastuzumab sourced in the European Union (EU-trastuzumab)*.

METHODS:

In this randomized, blinded, single-dose comparative PK study, healthy male subjects were randomized to receive a single 6 mg/kg IV dose of HD201 or EU-trastuzumab. The primary PK end point was AUC_0-∞. Equivalence was determined by using the predefined margins of 0.8 to 1.25. Other PK parameters were included as secondary end points.

FINDINGS:

Baseline demographic characteristics for the 73 randomized subjects were similar across the 2 groups: median age 29 and 30 years old (ranges 19 - 45), median weight 78.6 and 81.7 kg (ranges 60.2 - 101). The 90% CIs for the geometric least squares mean of the AUC_0-∞ were included within the margins of 0.8 to 1.25. All other PK parameters were comparable for both HD201 and EU-trastuzumab. The proportions of subjects who experienced adverse events related to the study drug were 61.8% and 82.9% in the HD201 and EU-trastuzumab groups, respectively. The most frequently reported adverse events related to the study drug were infusion-related reactions. No subjects had positive results for antidrug antibodies after a single dose.

IMPLICATIONS:

This study reported the PK equivalence between HD201 and EU-trastuzumab. HD201 was well tolerated with no safety concerns after single-dose administration in healthy male subjects. EudraCT No.: 2012-000805-56.

News (Medical) associated with Trastuzumab Biosimilar (Prestige BioPharma)

22 Apr 2026

·www.prnewswire.com

Prestige Biopharma IDC Files Patent for Next-Generation Antibody Delivery Platform 'IDC224'… Driving Innovation in Subcutaneous (SC) Formulations

SEOUL, South Korea, April 22, 2026 /PRNewswire/ -- Prestige Biopharma IDC, the innovative drug research institute of Prestige Biopharma, announced that it has filed a patent for 'IDC224,' a next-generation subcutaneous (SC) delivery platform designed to simultaneously enhance the administration convenience and therapeutic efficacy of antibody therapeutics. While most current antibody therapeutics are administered via intravenous (IV) infusion—typically requiring more than an hour and dedicated medical assistance—subcutaneous (SC) administration offers a rapid, highly convenient alternative for patients. Given the high patient convenience and the mitigation of risks associated with repeated vascular access, the global pharmaceutical and biotechnology industry is witnessing a strategic shift from IV to SC delivery methods. However, antibody therapeutics face significant technical barriers regarding the stable delivery of high-concentration formulations, necessitating advanced engineering for successful SC conversion. Prestige Biopharma IDC has addressed these challenges with the development of its proprietary IDC224 technology. The IDC224 platform is characterized by a unique liquid-to-gel transition mechanism; the drug is administered in a liquid state and subsequently transforms into a gel upon exposure to body temperature. This process facilitates the sustained release of the drug, effectively extending its therapeutic duration and reducing dosing frequency. Furthermore, the platform enables the uniform loading of high-concentration antibodies, thereby maximizing delivery efficiency. It also secures a strong competitive edge in safety by utilizing biocompatible and biodegradable materials. The project lead overseeing the development of IDC224 stated, "This platform was engineered to optimize the mode of administration, drug delivery efficiency, and patient convenience in tandem. In pre-clinical studies applying this platform to gastric, ovarian, and breast cancer models, we confirmed improved therapeutic efficacy compared to conventional methods." The representative added, "This patent is a follow-up to our existing composition patent and holds significant value as a 'use patent,' which newly defines the anticancer efficacy achieved through this specific composition." Notably, this technology is designed to facilitate the potential SC conversion of Tuznue®, Prestige Biopharma's trastuzumab biosimilar, which is currently approved in Europe in its existing formulation. This technology therefore holds substantial strategic value in further strengthening product competitiveness and enabling future differentiated administration options for patients and healthcare providers. A spokesperson for Prestige Biopharma IDC remarked, "The IDC224 platform is designed not only to enhance the durability of an antibody's therapeutic effect but also to improve ease of administration. We plan to expand the application of this technology to a diverse portfolio of antibody therapeutics in the future." About Tuznue® Tuznue® is a biosimilar of Herceptin® (trastuzumab), developed to offer a more cost-effective therapeutic alternative for patients. It maintains comparable efficacy and safety profiles to the original branded medication. Tuznue® is indicated for the treatment of patients with HER2-positive metastatic breast cancer (MBC), HER2-positive early breast cancer (EBC), and HER2-positive metastatic gastric cancer (MGC). About Prestige Biopharma Established in 2015 in Singapore, Prestige Biopharma is a biopharmaceutical company with a diversified portfolio. Among its many pipelines, a first-in-class antibody drug and key biosimilars referencing blockbuster drugs are ongoing clinical development. Notably, the first-in-class PAUF-based antibody drug, Ulenistamab, has received Orphan Drug Designation from the U.S. FDA, the European EMA, and the Korean MFDS, along with Fast Track Designation from the U.S. FDA. A global Phase 1/2a clinical trial is currently underway in the United States, Europe, and Asia, with the aim of bringing this innovative therapy to the clinic. 21% more press release views with Request a Demo

Orphan DrugFast Track

26 Nov 2025

·www.prnewswire.com

Prestige Biopharma and Biosidus Enter Exclusive License Agreement for Tuznue® Commercialization in Latin America

SINGAPORE, Nov. 26, 2025 /PRNewswire/ -- Prestige Biopharma, a biopharmaceutical company specializing in antibody therapeutics, today announced an exclusive license and supply agreement with Biosidus, a biotechnology company headquartered in Buenos Aires, Argentina, with decades of experience in biosimilar development and commercialization, for the commercialization of Tuznue® (trastuzumab) across Latin American markets, including Argentina, Mexico, Bolivia, and Paraguay. Tuznue® is a biosimilar to Herceptin® (trastuzumab), approved for the treatment of breast cancer and metastatic gastric cancer. Prestige Biopharma received European Commission (EC) marketing authorization for Tuznue® in September 2024. This approval marks a major milestone for the company's biosimilar portfolio, signaling progress in expanding access to cost-effective treatments across key global markets. Under the agreement, Biosidus secures exclusive rights to market and distribute Tuznue® in Argentina, Mexico, Bolivia, and Paraguay, leveraging its extensive commercial network and deep expertise in biosimilar adoption. Prestige Biopharma will be responsible for the production and supply of the drug substance through its EU-GMP-certified, high-tech facility equipped with advanced single-use technology. Biosidus will manufacture the drug product at its facility in Buenos Aires, Argentina, from which it will supply the product to the local market, and export the product to the markets of Mexico, Paraguay and Bolivia. Lisa S. Park, CEO of Prestige BioPharma, commented: "We are pleased to announce our strategic partnership with Biosidus for Argentina and other key markets in Latin America. With its proven track record and deep regional expertise, Biosidus represents an ideal partner for the successful manufacturing and commercialization of our lead biosimilar. We are confident that this collaboration will further enhance the global value and reach of our biosimilar portfolio." Mariano Elizalde, CEO of Biosidus, said: "We are proud to partner with Prestige Biopharma to introduce Tuznue® in selected markets across Latin America. This agreement strengthens our Biosimilars portfolio and our commitment to expand access to biotechnological medicines in Latin America. Together with Prestige Biopharma, we are confident in offering patients and healthcare professionals a quality and affordable therapeutic option". About Tuznue® Tuznue® is a biosimilar of Herceptin® (trastuzumab), developed to offer a more cost-effective therapeutic alternative for patients. It maintains comparable efficacy and safety profiles to the original branded medication. Tuznue® is indicated for the treatment of patients with HER2-positive metastatic breast cancer (MBC), HER2-positive early breast cancer (EBC), and HER2-positive metastatic gastric cancer (MGC). About Prestige Biopharma Established in 2015 in Singapore, Prestige Biopharma is a biopharmaceutical company with a diversified portfolio. Among its many pipelines, a first-in-class antibody drug and key biosimilars referencing blockbuster drugs are ongoing clinical development. Notably, the first-in-class PAUF-based antibody drug, ulenistamab, has received Orphan Drug Designation from the U.S. FDA, the European EMA, and the Korean MFDS, along with Fast Track Designation from the U.S. FDA. A global Phase 1/2a clinical trial is currently underway in the United States, Europe, and Asia, with the aim of bringing this innovative therapy to the clinic. About Biosidus Biosidus is an Argentine company, a pioneer in biotechnology, which over the last 42 years has achieved a leadership position in Latin America and a growing share in other emerging markets in Asia, Africa and Eastern Europe, developing, producing and marketing biopharmaceuticals of the highest quality at affordable prices. 21% more press release views with Request a Demo

Orphan DrugLicense out/inDrug ApprovalFast Track

01 Aug 2024

·www.prnewswire.com

Prestige Biopharma's Herceptin Biosimilar Tuznue® Receives Positive CHMP Opinion from the EMA

Following approval by the European Commission, Prestige Biopharma's Herceptin biosimilar Tuznue® would become the first biosimilar from a Singaporean company to be authorized in the European Union. SINGAPORE, Aug. 1, 2024 /PRNewswire/ -- Prestige Biopharma, a pioneer in biopharmaceuticals, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for Tuznue®, a Herceptin (trastuzumab) biosimilar. This milestone positions Prestige Biopharma to become the first Singaporean firm to commercialize its biosimilar in the European Union. The CHMP's positive opinion is based on clinical evidence from Phase 1 and Phase 3 clinical studies that tested the biosimilarity of Tuznue® to Herceptin®. The Phase 1 clinical PK study in healthy volunteers demonstrated PK equivalence, as well as similarity in safety and immunogenicity. Finally, the global Phase 3 confirmatory efficacy and similarity study met its primary endpoint and demonstrated similarity in efficacy, PK, safety, and immunogenicity in HER2-positive patients with early breast cancer. This favourable decision is a crucial step toward final approval from the European Commission (EC). Once approved, Tuznue® will be commercialized across Europe. Prestige Biopharma has already established licensing agreements with major pharmaceutical partners for global marketing and sales. These agreements are set to generate immediate milestone payments and provide early revenue for the company. Negotiations are also underway to ensure a strong market entry for Tuznue® in Europe. "Receiving a positive CHMP opinion for Tuznue® marks a major milestone for Prestige Biopharma, significantly advancing our revenue generation strategy and accelerating future pipeline approvals," said Lisa Park, the CEO of Prestige Biopharma. "This recognition solidifies our position as a leading biosimilar developer. We are committed to leveraging this achievement to enhance our market presence and drive continued success." About TUZNUE® (HD201, Herceptin biosimilar) Tuznue® is a biosimilar of Herceptin® (trastuzumab), developed to offer a more cost-effective therapeutic alternative for patients. It maintains comparable efficacy and safety profiles to the original branded medication. Tuznue® is indicated for the treatment of patients with HER2-positive metastatic breast cancer (MBC), HER2-positive early breast cancer (EBC), and HER2-positive metastatic gastric cancer (MGC). About Prestige Biopharma: Established in 2015 in Singapore and listed in the Korea Exchange in 2021 (KOSPI: 950210), Prestige Biopharma Limited is a biopharmaceutical company with a diversified portfolio, including biosimilars (HD204 Avastin biosimilar in filing stage, PBP1502 Humira biosimilar in clinical stage) and new antibody drugs. Among its many pipelines, a first-in-class antibody drug and key biosimilars referencing blockbuster drugs are ongoing clinical development. Notably, the first-in-class, PAUF-based antibody drug, Ulenistamab, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) in Korea, as well as Fast Track Designation by the U.S. FDA. A global Phase 1/2a clinical trial is currently underway in the United States, Europe, and Asia, with the aim of bringing this innovative therapy to the clinic. Contacts Prestige Biopharma Group Donghee Im [email protected] Logo -

Clinical ResultOrphan DrugLicense out/inPhase 3Fast Track

100 Deals associated with Trastuzumab Biosimilar (Prestige BioPharma)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 Positive Breast Cancer	European Union	Prestige BioPharma Ltd.	19 Sep 2024
HER2 Positive Breast Cancer	Iceland	Prestige BioPharma Ltd.	19 Sep 2024
HER2 Positive Breast Cancer	Liechtenstein	Prestige BioPharma Ltd.	19 Sep 2024
HER2 Positive Breast Cancer	Norway	Prestige BioPharma Ltd.	19 Sep 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breast	European Union	Prestige BioPharma Ltd.	19 Sep 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Iceland	Prestige BioPharma Ltd.	19 Sep 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Liechtenstein	Prestige BioPharma Ltd.	19 Sep 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Norway	Prestige BioPharma Ltd.	19 Sep 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HER2 positive Gastroesophageal Junction Adenocarcinoma	NDA/BLA	European Union	Prestige BioPharma Ltd.	25 Jul 2024
HER2 Positive Stomach Adenocarcinoma	NDA/BLA	European Union	Prestige BioPharma Ltd.	25 Jul 2024
Stomach Cancer	NDA/BLA	Canada	Prestige BioPharma Ltd.	01 Aug 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03013504 (TROIKA, ESMO_ASIA2022) Manual	Phase 3	HER2 Positive Breast Cancer Neoadjuvant ERBB2-positive	474	HD201 6 mg/kg/8 mg/kg+docetaxel+epirubicin+cyclophosphamide	qhhdmwisdz(grxrplqznb) = vcflaifxhu vrerakzejo (ztpgcjsljv ) View more	Similar	03 Dec 2022
				Trastuzumab 6 mg/kg/8 mg/kg+docetaxel+epirubicin+cyclophosphamide	qhhdmwisdz(grxrplqznb) = gdcggasjil vrerakzejo (ztpgcjsljv ) View more
NCT03013504 (TROIKA, Pubmed \| JAMA Oncol) Manual	Phase 3	HER2 Positive Breast Cancer Neoadjuvant ERBB2 Positive	502	docetaxel+epirubicin+cyclophosphamide+HD201	dxwhkimygo(xdghevpbxl) = aodxvszabu kvnqfxahdo (zirjryhvsx ) View more	Similar	03 Mar 2022
				docetaxel+epirubicin+cyclophosphamide+Trastuzumab	dxwhkimygo(xdghevpbxl) = ipbedtybah kvnqfxahdo (zirjryhvsx ) View more
NCT03776240 (TROIKA-1, Pubmed \| Pharmacol Res Perspect) Manual	Phase 1	-	105	HD201	xmxautzevn(kymqrsmyrl) = were within 80%-125% for the comparisons of HD201 to EU-Herceptin or US-Herceptin and EU-Herceptin to US-Herceptin ezwyebqbus (sxmacbywcs )	Positive	01 Aug 2021
				Herceptin
EUCTR2016-004019-11-ES (TROIKA, ESMO2020) Manual	Phase 3	HER2 Positive Breast Cancer Neoadjuvant HER2 Positive	503	HD201+chemotherapy	zfmoglbzly(gixkmqlptw) = ekaxytdngl hvznyxwgtg (ahhiaravqf ) View more	Similar	18 Sep 2020
				Herceptin+chemotherapy	zfmoglbzly(gixkmqlptw) = bmfsemqrfg hvznyxwgtg (ahhiaravqf ) View more

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