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.

Article excerpt reposted from cnbctv18.com

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.

Article excerpt reposted from cnbctv18.com

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.

Article excerpt reposted from cnbctv18.com

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.

Aurobindo Pharma on Tuesday said its subsidiary CuraTeQ Biologics has expanded the scope of its marketing and distribution agreement with Orion Corporation (Orion).

Aurobindo Pharma on Tuesday said its subsidiary CuraTeQ Biologics has expanded the scope of its marketing and distribution agreement with Orion Corporation (Orion) to commercialise its biosimilars pipeline to include the Baltic states in Europe.

Under the terms of the agreement, Orion will be responsible for commercialisation of CuraTeQ’s biosimilar products, currently in various stages of development/filing for the partnered territories, Aurobindo Pharma said in regulatory filing.

CuraTeQ filed its first oncology biosimilar product with the European Medicines Agency (EMA) in September 2021 and filed its second biosimilar product, also in the oncology segment on January 10, 2022.

“We remain committed to expand the reach of our affordable, high quality products to patients globally and the strengthening of partnership with Orion provides our biosimilar products a pan-Europe access. We are encouraged with our progress on biosimilars development and look forward to execution of the same in the coming years,” Aurobindo Pharma Vice Chairman & Managing Director Nithyananda Reddy stated.

CuraTeQ CEO Satakarni Makkapati said Orion has a demonstrated and proven track record of successfully commercialising biosimilars in the Nordic and Baltic states in Europe.

“Orion’s understanding of the biosimilars adoption along with extensive commercial infrastructure in the NORDICS and other territories in the EEA make it an ideal partner to expand the accessibility of our biosimilar products in selected markets of Europe, complementing our group’s wide footprint in other European markets, he stated.

Orion Corporation SVP Specialty Products Virve Laitinen said the agreement will strengthen the company’s position as one of the leading generics providers in the Nordics and Baltics.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

Article reposted from Business Standard

Aurobindo Pharma Limited is pleased to announce the acquisition of four cell culture derived biosimilar products from TL Biopharmaceutical AG.

As part of this agreement, TL will supply all the developmental data for four molecules and Aurobindo and/or its affiliates will develop, commercialise and market these products globally. The branded market size of these four biosimilars, three of them monoclonal antibodies in oncology is very promising. Regulatory filing for these products is intended in the period 2020-22.

Aurobindo is preparing to take its lead molecule from this transaction, a Bevacizumab biosimilar, for clinical trials in 2017. Bevacizumab is an anti-antiogenesis drug used in treating multiple-cancers including metastatic colon or rectal cancer, non-squamous and non-small cell lung cancers.

This transaction is a strategic investment for future growth and will position Aurobindo as a strong player in the rapidly evolving biosimilars landscape. Building on these first four products licensed from TL, Aurobindo is expanding its diverse portfolio of eight more next wave of biosimilars ensuring a strong and diverse products pipeline. Aurobindo has set up a fully functional R&D centre for biologics development and is also establishing a state-of-art manufacturing facility in Hyderabad, Telangana which would be ready by Q2, FY 18

Commenting on the strategic alliance, Mr. N. Govindarajan, Managing Director of Aurobindo Pharma Limited said: “We are impressed with TL’s product development as these are developed to the highest standards of biosimilarity. This acquisition is in-line with our strategy of investing in complex products and is an important first step towards establishing Aurobindo’s global biosimilars portfolio.”

Article reposted from Biosimilar Development