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
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 |
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
HD204
Bevacizumab Biosimilar
(Avastin® Biosimilar)
Therapeutic Area: Oncology
Detailed Information
–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 |
Detailed Information
–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 |
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
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.
