Breast Cancer Archives - CuraTeQ Biologics https://curateqbio.com/tag/breast-cancer/ Mon, 22 Jan 2024 10:28:08 +0000 en-US hourly 1 https://wordpress.org/?v=6.9 https://static.curateqbio.com/wp-content/uploads/2023/02/cropped-CuraTeQ-Favicon-32x32.png Breast Cancer Archives - CuraTeQ Biologics https://curateqbio.com/tag/breast-cancer/ 32 32 CuraTeQ Biologics’ Trastuzumab Biosimilar receives recommendation for marketing authorization in India https://curateqbio.com/curateq-biologics-trastuzumab-biosimilar-receives-recommendation-for-marketing-authorization-in-india/ https://curateqbio.com/curateq-biologics-trastuzumab-biosimilar-receives-recommendation-for-marketing-authorization-in-india/#respond Wed, 17 Jan 2024 10:08:50 +0000 https://curateqbio.com/?p=2505 The post CuraTeQ Biologics’ Trastuzumab Biosimilar receives recommendation for marketing authorization in India appeared first on CuraTeQ Biologics.

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Aurobindo Pharma Ltd’s wholly-owned subsidiary, CuraTeQ Biologics Private Ltd, on Wednesday, January 17, received marketing authorisation from the Central Drugs Standard Control Organization (CDSCO) for biosimilar trastuzumab.

In a stock exchange filing, Aurobindo Pharma said that CuraTeQ Biologics received a recommendation for grant of marketing authorisation of biosimilar trastuzumab from the Subject Experts Committee (SEC) of CDSCO, the apex drug regulator in India.

Trastuzumab biosimilar is a humanised monoclonal antibody that is used in the treatment of metastatic breast cancer and early breast cancer.

This monoclonal antibody is supplied in single dose glass vials that contain lyophilized powder in the dosages of 150 mg and 420 mg as concentrate for solution for infusion, Aurobindo Pharma informed the bourses.
CuraTeQ was asked to submit Phase IV clinical trial protocol to CDSCO within three months of receiving the marketing authorisation.

Article excerpt reposted from cnbctv18.com

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]]> https://curateqbio.com/curateq-biologics-trastuzumab-biosimilar-receives-recommendation-for-marketing-authorization-in-india/feed/ 0 CuraTeQ Biologics announces positive Phase-3 results for Trastuzumab biosimilar https://curateqbio.com/curateq-biologics-announces-positive-phase-3-results-for-trastuzumab-biosimilar/ https://curateqbio.com/curateq-biologics-announces-positive-phase-3-results-for-trastuzumab-biosimilar/#respond Wed, 05 Jul 2023 07:42:00 +0000 https://curateq.in-testing.co.uk/?p=2350 The post CuraTeQ Biologics announces positive Phase-3 results for Trastuzumab biosimilar appeared first on CuraTeQ Biologics.

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Shares of Aurobindo Pharma gained in the early trade on July 5 after subsidiary CuraTeQ Biologics announced positive results in the phase-3 clinical trial of Trastuzumab biosimilar.

The breast cancer biosimilar product, BP02 (Trastuzumab or biosimilar to Herceptin), developed by the wholly owned subsidiary Curateq Biologics Private Limited, has met its primary endpoint in the Phase-3 clinical trial, according to a statement from Aurobindo Pharma.

BP02 has shown equivalent efficacy to Herceptin in regard to its clinical response (overall response rate, ORR), in addition to demonstrating a comparable safety profile.

This Phase-3 study is a multi-centre, randomised, double-blinded study involving females with metastatic HER2- positive breast cancer, the company said.

The trial was carried out to demonstrate product equivalence in terms of efficacy vis-à-vis EU-sourced Herceptin. Additionally, the trial also compared pharmacokinetics, safety, and immunogenicity of BP02 vs originators product, it added.

The results demonstrated that BP02 met equivalence to Herceptin in terms of clinical response and the safety profiles of the two treatment arms were shown to be comparable during the treatment phase.

Earlier, CuraTeQ completed a randomised, double-blind, parallel three-arm Phase-1 study (BP02-101) in healthy volunteers with BP02 and Herceptin sourced from the US and the EU.

“We are excited by this study outcome. CuraTeQ is in the process of initiating submissions to regulatory agencies starting this quarter. We hope to complete market authorization (MA) application submissions across all key regulated markets in a phased manner, by March 2024. Our first submission will be in India in July 2023,” said Dr Satakarni Makkapati, CEO, Biosimilars, Vaccines and Peptides.

On July 3, the company’s entity entered into an arrangement with Viatris Inc for an aggregate value of $48 million in relation to transfer from Viatris Inc of certain marketing and manufacturing related authorisations that will be subject to approval from applicable regulatory authorities and third parties.

The arrangement also contemplates participation in the supply system in relation to certain marketing and manufacturing related authorisations and sharing of the net economic benefits by Viatris Inc. to such group entity of the company, it added.

At 9:28am, Aurobindo Pharma was quoting at Rs 716.30, up Rs 3.65, or 0.51 percent on the BSE.

The share touched a 52-week high of Rs 741.40 and a 52-week low of Rs 397.30 on 28 June, 2023 and 03 February, 2023, respectively. It is trading 3.39 percent below its 52-week high and 80.29 percent above its 52-week low.

Article reposted from Money Control

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