Delving into the Latest Updates on Trastuzumab biosimilar(CuraTeQ Biologics) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Trastuzumab Biosimilar (Aurobindo Pharma Ltd.), 曲妥珠单抗生物类似药（Aurobindo Pharma Ltd.）, BP-02

+ [1]

Target

HER2

Action

antagonists

Mechanism

HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal Diseases

Active Indication

Metastatic human epidermal growth factor 2 positive carcinoma of breastHER2 Positive Breast Cancer

Inactive Indication-

Originator Organization

Aurobindo Pharma Ltd.

Active Organization

Curateq Biologics Pvt Ltd.

Inactive Organization-

License Organization

Orion OyjCurateq Biologics Pvt Ltd.

Drug Highest PhaseApproved

First Approval Date

European Union (30 Jun 2025),

Metastatic human epidermal growth factor 2 positive carcinoma of breast

Regulation-

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Structure/Sequence

Sequence Code 18481L

The sequence is quoted from: *****

Sequence Code 44772H

The sequence is quoted from: *****

In this phase 1, double-blind, parallel-group trial, 111 healthy male volunteers were randomized 1:1:1 to receive a single 6-mg/kg intravenous infusion of BP02, EU-trastuzumab, or US-trastuzumab and were evaluated for 78 days. Serum drug concentration-time data were analyzed by non-compartmental methods. The PK similarity of BP02 to the two reference products, and between EU-trastuzumab and US-trastuzumab, was determined using the standard 80-125% bioequivalence criteria.

RESULTS:

Baseline demographics for the 111 subjects with evaluable pharmacokinetics were similar across all treatment groups. PK profiles were similar for the three products. The 90% confidence intervals (CIs) for the ratios of area under the serum concentration-time curve (AUC) from the time of dosing to infinity (AUC_0-inf), AUC from the time of dosing until the time of the last quantifiable concentration (AUC_0-t), and peak serum concentration of trastuzumab (C_max) were within 80% to 125% for all three pairwise comparisons. Adverse events (AEs) were similar across all arms, with treatment-related AEs reported by 73.0%, 73.0%, and 89.2% of the subjects in the BP02, EU-trastuzumab, and US-trastuzumab groups, respectively. The most common AEs were headache, infusion-related reactions, and upper-respiratory-tract infections. Four subjects-three in the US-trastuzumab group and one in the BP02 group-discontinued the study due to AEs. All post-dose samples except for two tested negative for anti-drug antibodies.

CONCLUSION:

This study demonstrates the PK similarity among BP02, EU-trastuzumab, and US-trastuzumab. The safety and immunogenicity profiles observed for the three products in this study are consistent with previous reports for trastuzumab.

TRIAL REGISTRATION:

ANZCTR number: ACTRN12621000573853.

01 Jul 2024·Clinical Drug Investigation

Efficacy and Safety of BP02 (Trastuzumab Biosimilar) in HER2-Positive Metastatic Breast Cancer: A Multicenter Phase III Study

Article

Author: Dadke, Disha ; Santa, Ayyagari ; Rao Srikanth, Ranganatha ; Mandal, Srikrishna ; Khane, Shriram ; Prajapati, Arpitkumar ; Kothari, Rushabh ; Nagarkar, Rajnish ; Mohan, M V T Krishna

BACKGROUND AND OBJECTIVE:

Trastuzumab targets human epidermal growth factor receptor 2 (HER2) receptors and is indicated for treating HER2-positive metastatic breast cancer. BP02, a recombinant IgG1 kappa humanized monoclonal antibody, is being developed as a trastuzumab biosimilar. The objective of this study was to evaluate the equivalence of BP02 with reference trastuzumab (RT: Herceptin^®-EU) in patients with HER2-positive metastatic breast cancer.

METHODS:

This double-blinded, 1:1 randomized, parallel-group, active-controlled, phase III equivalence trial recruited women aged 18-75 years with histologically/cytologically confirmed HER2- positive, locally recurrent or metastatic breast cancer with systemic metastasis, from 59 sites in India. Patients were randomly allocated 1:1 stratified by estrogen receptor/progesterone receptor status to receive BP02/RT (8-mg/kg loading dose on day 1-cycle 1, 6 mg/kg on day 1-cycles 2-8, of each 3-week cycle) combined with docetaxel (75 mg/m² on day 1-cycles 1-8) [induction phase]. Participants with complete or partial response, or stable disease at the end of the induction phase continued the study drug until disease progression/treatment discontinuation [maintenance phase]. The primary efficacy endpoint was the objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

RESULTS:

Between 23 September, 2020 and 16 September, 2022, 690 patients were recruited (n = 345 each to BP02/RT). At the end of the induction phase (intent-to-treat population), a similar proportion of patients achieved an objective response rate with BP02 (n = 231 [67.0%], 95% confidence interval [CI] 62.0, 71.9) and RT (n = 238 [69.0%], 95% CI 64.1, 73.9). The 95% CI of risk difference (-2.03, 95% CI -9.15, 5.09) and 90% CI of risk ratio (0.97, 90% CI 0.89, 1.06) were within equivalence margins of ± 13% and (0.80, 1.25), respectively. Treatment-emergent adverse events leading to treatment withdrawal were reported in 2.9% and 3.2% patients with BP02 and RT, respectively.

CONCLUSIONS:

BP02 showed an equivalent efficacy and similar safety profile to RT at the end of 24 weeks.

CLINICAL TRIAL REGISTRATION:

CTRI Number: CTRI/2020/04/024456.

1

News (Medical) associated with Trastuzumab biosimilar(CuraTeQ Biologics)

17 Dec 2024

·pharma.economictimes.indiatimes.com

Aurobindo Pharma arm CuraTeQ gets positive EMA opinion for biosimilar Zefylti

Hyderabad: Aurobindo Pharma ’s wholly-owned subsidiary, CuraTeQ Biologics Private Limited , received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European drug regulatory body, the European Medicines Agency ( EMA ), for its filgrastim biosimilar , Zefylti. The committee recommended granting marketing authorisation. The Hyderabad-based company stated that Zefylti is its first biosimilar to receive a positive opinion from the EMA’s CHMP after it received the GMP (good manufacturing practices) certificate from the EMA in November this year. Zefylti, codenamed BP13, is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells (PBPCs). It will be available in dosages of 30 MU per 0.5 mL and 48 MU per 0.5 mL. “Two more products, our biosimilar versions of pegylated filgrastim (BP14) and trastuzumab (BP02), are currently under review with the EMA, and a biosimilar to bevacizumab (BP01) is under review with the UK-MHRA. We are confident and on track to bring these treatment options to patients next year,” Aurobindo Pharma stated. The Hyderabad-headquartered CuraTeQ is a global biopharmaceutical company focused on developing biosimilars for the treatment of various cancers and autoimmune diseases. It currently has a pipeline of 14 biosimilars for the oncology and immunology segments. The company has end-to-end capabilities in producing a range of products, from bulk drug substances to fill-finish and packaged drug products. By Swati Bharadwaj ,

BiosimilarDrug Approval

100 Deals associated with Trastuzumab biosimilar(CuraTeQ Biologics)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic human epidermal growth factor 2 positive carcinoma of breast	European Union	Curateq Biologics Pvt Ltd.	30 Jun 2025
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Iceland	Curateq Biologics Pvt Ltd.	30 Jun 2025
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Liechtenstein	Curateq Biologics Pvt Ltd.	30 Jun 2025
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Norway	Curateq Biologics Pvt Ltd.	30 Jun 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HER2 Positive Breast Cancer	NDA/BLA	India	Curateq Biologics Pvt Ltd.	17 Jan 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTRI/2020/04/024456 (BP02, ESMO_ASIA2023)	Phase 3	Metastatic breast cancer Maintenance HER2+ve	690	BP02	nqcjmectlk(afiaacvekf) = kmqtzlcnti qaptxrurey (zilzldquot, 62.0 - 71.9)	Positive	02 Dec 2023
				Reference trastuzumab (RT: Herceptin-EU)	nqcjmectlk(afiaacvekf) = kyzufxdwhw qaptxrurey (zilzldquot, 64.1 - 73.9)

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Biosimilar

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