Biosimilars

Improving Accessibility

and Affordability of Existing Biological Drugs

Prestige Biopharma believes in the potential of biosimilars and the contribution they make towards establishing a sustainable future for biologic medicines. Our goal is to enhance patient treatment accessibility by offering biological medicines that are affordable, safe, and of high quality. Our portfolio consists of 12 biosimilars, including, HD201 (trastuzumab biosimilar) currently under regulatory review, HD204 (bevacizumab biosimilar) in Phase 3 clinical study and PBP1502 (adalimumab biosimilar) in Phase 1 clinical study.

Our groundbreaking accomplishments

Biosimliar Pipeline

First-in-Class

HD201
Trastuzumab Biosimilar
(Herceptin® biosimilar)
Therapeutic Area: Oncology

Detailed Information

Indication: Breast cancer, Gastric cancer
Presentations: 150mg and 440mg powder for concentrate for solution for infusion
-Patent protected technology
Status: MAA filing to EMA

Clinical Development Prgram
An Overview

Protocol number / Study type Title of the study Status
TROIKA-1(Pivotal PK similarity) A Double-blind, Randomized, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 Versus EU-Herceptin and US-Herceptin in Healthy Male Subjects Completed
EAGLE-I-12 (PK similarity) A Phase I, Double-blind, Randomized, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and Herceptin in Healthy Male Subjects Completed
TROIKA (Clinical similarity) A Randomized, Double-blind, Parallel-group, Equivalence, Multicentre Phase Ill trial to compare the Efficacy, Safety, and PKs of HD201 to EU-Herceptin in Patients with HER2-positive Early Breast Cancer Completed

Publications
– Pivot X, Georgievich MA, Shamrai V, Dzagnidze G, Soo Hoo HF, Kaewkangsadan V, Petrelli F, Villanueva C, Nikolaevich LO, Hii J, Kim J, Pradhan S, Jaison L, Feyaerts P, Kaufman L, Derde MP, Bonamy GMC, Deforce F, Cox DG. Efficacy of HD201 vs Referent Trastuzumab in Patients With ERBB2-Positive Breast Cancer Treated in the Neoadjuvant Setting: A Multicenter Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 May 1;8(5):698-705. doi: 10.1001/jamaoncol.2021.8171. Erratum In: JAMA Oncol. 2022 May 1;8(5):784.

– Final analysis of the phase 3 randomized clinical trial comparing HD201 vs. referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting

Detailed Information

Indication: Breast cancer, Gastric cancer
Presentations: 150mg and 440mg powder for concentrate for solution for infusion
-Patent protected technology
Status: MAA filing to EMA

Clinical Development Prgram
An Overview

TROIA-1 (Picotal PK similarity)

A Double-blind, Randomized, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 Versus EU-Herceptin and US-Herceptin in Healthy Male Subjects
Status Completed

EAGLE-Ⅰ-12 (PK similarity)

A Phase I, Double-blind, Randomized, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and Herceptin in Healthy Male Subjects
Status Completed

TROIA-1 (Clinical similarity)

A Randomized, Double-blind, Parallel-group, Equivalence, Multicentre Phase Ill trial to compare the Efficacy, Safety, and PKs of HD201 to EU-Herceptin in Patients with HER2-positive Early Breast Cancer
Status Completed

Publications

– Pivot X, Georgievich MA, Shamrai V, Dzagnidze G, Soo Hoo HF, Kaewkangsadan V, Petrelli F, Villanueva C, Nikolaevich LO, Hii J, Kim J, Pradhan S, Jaison L, Feyaerts P, Kaufman L, Derde MP, Bonamy GMC, Deforce F, Cox DG. Efficacy of HD201 vs Referent Trastuzumab in Patients With ERBB2-Positive Breast Cancer Treated in the Neoadjuvant Setting: A Multicenter Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 May 1;8(5):698-705. doi: 10.1001/jamaoncol.2021.8171. Erratum In: JAMA Oncol. 2022 May 1;8(5):784.

– Final analysis of the phase 3 randomized clinical trial comparing HD201 vs. referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting

HD204
Bevacizumab Biosimilar
(Avastin® Biosimilar)

Therapeutic Area: Oncology

Detailed Information
-Indication: Solid tumors
Presentations: 400mg in studies, 100mg planned to file
-Patent protected technology
Status: Global phase 3 clinical trial

Clinical Development Prgram
An Overview

Protocol number / Study type Title of the study Status
SAMSON-1 A Phase I, double-blind, randomized, parallel group study to demonstrate the equivalent pharmacokinetic Properties of a Single Intravenous Dose of HD204, US-Avastin® and EU-Avastin® in Healthy Male Subjects Completed
SAMSON-2 A randomized, double-blind, parallel group, equivalence, Multi-centre Phase III trial to compare the efficacy, safety, pharmacokinetics and immunogenicity of HD204 to Avastin® in patients with metastatic or recurrent Non-squamous Non-small Cell Lung Cancer ongoing

Publications
Demarchi M, Coliat P, Barthelemy P, Schott R, BenAbdelghani M, Kim M, Hii JCS, Feyaerts P, Ang FRX, Derde MP, Deforce F, Petit T, Schwabe C, Wynne C, Park LS, Pivot X. A randomized phase I study comparing the pharmacokinetics of a bevacizumab (HD204) biosimilar to European Union- and United States of America-sourced bevacizumab. PLoS One. 2021 Sep 23;16(9):e0248222. doi: 10.1371/journal.pone.0248222. eCollection 2021.

Detailed Information
-Indication: Solid tumors
Presentations: 400mg in studies, 100mg planned to file
-Patent protected technology
Status: Global phase 3 clinical trial

Clinical Development Prgram
An Overview

SAMSON-1

A Phase I, double-blind, randomized, parallel group study to demonstrate the equivalent pharmacokinetic Properties of a Single Intravenous Dose of HD204, US-Avastin® and EU-Avastin® in Healthy Male Subjects
Status Completed

SAMSON-2

A randomized, double-blind, parallel group, equivalence, Multi-centre Phase III trial to compare the efficacy, safety, pharmacokinetics and immunogenicity of HD204 to Avastin® in patients with metastatic or recurrent Non-squamous Non-small Cell Lung Cancer
Status Ongoing

Publications
Demarchi M, Coliat P, Barthelemy P, Schott R, BenAbdelghani M, Kim M, Hii JCS, Feyaerts P, Ang FRX, Derde MP, Deforce F, Petit T, Schwabe C, Wynne C, Park LS, Pivot X. A randomized phase I study comparing the pharmacokinetics of a bevacizumab (HD204) biosimilar to European Union- and United States of America-sourced bevacizumab. PLoS One. 2021 Sep 23;16(9):e0248222. doi: 10.1371/journal.pone.0248222. eCollection 2021.

PBP1502
Adalimumab Biosimilar
(Humira® Biosimilar)
Therapeutic Area: Immunology

Detailed Information

Indication: Arthritis
– Patent protected technology
Status: Phase 1 clinical trial ongoing

Clinical Development Prgram
An Overview

Protocol number / Study type Title of the study Status
SAMSON-1 A Phase 1, Double-blind, Randomized, Three-arm,
Parallel Group Study to Compare the Pharmacokinetics
and Safety of a Single Subcutaneous Dose of PBP1502,
EU-Humira®, and US-Humira® in Healthy Male and
Female Subjects
Completed

 

Detailed Information

Indication: Arthritis
– Patent protected technology
Status: Phase 1 clinical trial ongoing

Clinical Development Prgram
An Overview

SAMSON-1

A Phase 1, Double-blind, Randomized, Three-arm, Parallel Group Study to Compare the Pharmacokinetics and Safety of a Single Subcutaneous Dose of PBP1502, EU-Humira®, and US-Humira® in Healthy Male and Female Subjects
Status Completed

 

PBP1601
Denosumab Biosimilar
(Prolia® Biosimilar)
Therapeutic Area: Endocrinology

PBP1602
Aflibercept Biosimilar
(Eylea® Biosimilar)
Therapeutic Area: Ophthalmology

PBP1701
Ipilimumab Biosimilar
(Yervoy® Biosimilar)

Therapeutic Area: Oncology

PBP1801
Pertuzumab Biosimilar
(Perjeta® Biosimilar)

Therapeutic Area: Oncology

PBP2001
Ramucirumab Biosimilar
(Cyramza® Biosimilar)

Therapeutic Area: Oncology

PBP2002
Natalizumab Biosimilar
(Tysabri® Biosimilar)

Therapeutic Area: Immunology

PBP2101
Nivolumab Biosimilar
(Opdivo® Biosimilar)

Therapeutic Area: Oncology

PBP2102
Pembrolizumab Biosimilar
(Keytruda® Biosimilar)

Therapeutic Area: Oncology

Development of Novel Antibody Therapeutics

We are expanding the scientific knowledge obtained through biosimilar research and development, into the fields of  first-in-class antibody therapies and vaccines. We are currently conducting major clinical trials for PBP 1510 (Ulenistamab) to contribute to the treatment of pancreatic cancer. Our commitment remains unwavering as we continue to explore solutions for complex and resistant cancers and diseases.