CuraTeQ Biologics | Business Upturn

Aurobindo Pharma’s CuraTeQ Biologics receives Health Canada nod for Bevqolva biosimilar

Arunika Jain — Fri, 01 May 2026 08:28:07 +0000

CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has secured a Notice of Compliance (NOC) from Health Canada for its bevacizumab biosimilar, Bevqolva. The approval from Health Canada’s Biologics and Radiopharmaceutical Drugs Directorate (BRDD) grants formal marketing authorisation, confirming the biosimilar meets the regulatory standards for safety, efficacy, and quality comparable to the reference biologic drug.

Bevacizumab, a humanised monoclonal antibody, functions by inhibiting angiogenesis, the formation of new blood vessels, through blocking vascular endothelial growth factor A (VEGF-A). This mechanism is crucial in slowing tumour vascular growth and is used in the treatment of multiple cancers, including colorectal and lung cancer. The originator product, Avastin, is marketed by Roche/Genentech and is available in 100 mg and 400 mg formulations.

In 2025, Bevqolva received marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) and was commercially launched for patients across the UK. The product is also under review by the Committee for Medicinal Products for Human Use (CHMP) with the European Medicines Agency. Additionally, CuraTeQ Biologics has two more biosimilar applications currently under review by Health Canada.

Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).

Aurobindo Pharma’s CuraTeQ Biologics announces positive results for omalizumab biosimilar study

Arunika Jain — Mon, 06 Apr 2026 10:32:02 +0000

CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma, has announced positive top-line results from its Phase 3 study of BP11, an investigational biosimilar to Xolair® (omalizumab). The study, which involved 608 patients across approximately 80 sites in seven European countries and India, successfully met all primary endpoints. It demonstrated high comparability to the reference product in patients with chronic spontaneous urticaria (CSU) at the 300 mg dose.

The trial evaluated the change from baseline in ISS7 (7-point Itch Severity Score) at Week 12, the main primary endpoint applicable for both FDA and EMA approvals. The results showed precise equivalence, with tight confidence intervals well within the predefined margins of -2.5 to 2.0. The co-primary endpoint of relative potency, based on change from baseline in ISS7 at Week 12 using a 4-point assay, also met its criteria, demonstrating parallelism between BP11 and Xolair across dose levels. These outcomes reflect well-contained variability, robustness of data, and strong efficacy alignment, supporting regulatory submissions targeting CSU, allergic asthma, and CRSwNP (Chronic Rhinosinusitis with Nasal Polyps).

“These Phase 3 results with narrow confidence intervals validate our clinical strategy and the team’s execution in delivering a high-quality biosimilar. Detailed results will be submitted for regulatory review and presented at upcoming medical conferences,” said Dr. Arpitkumar Prajapati, Head of Clinical Development.

Dr. Disha Dadke, Head of R&D and Regulatory Sciences, added, “BP11 demonstrates comparable efficacy and safety to Xolair, paving the way for patient access to affordable treatment options. We are planning to complete filing of BP11 with both EMA and FDA by the end of Q2 2026.”

Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).

Aurobindo Pharma subsidiary CuraTeQ Biologics enters EU biosimilars agreement with STADA

Kinjal — Wed, 25 Mar 2026 11:26:58 +0000

CuraTeQ Biologics Pvt Ltd, a wholly owned subsidiary of Aurobindo Pharma Ltd, has entered into a marketing and distribution agreement with STADA Arzneimittel AG, a leading European healthcare and pharmaceuticals company. Under the terms of the agreement, STADA will market and distribute two EMA approved biosimilars developed by CuraTeQ in select European Union territories, including France and Germany. This strategic partnership is expected to expand CuraTeQ’s market reach and drive revenue growth by leveraging STADA’s established distribution network in EU markets. New brand names will be created and registered for each biosimilar, enhancing their market presence. The agreement signifies a significant step for CuraTeQ in strengthening its position in the European biosimilars market, although it is not classified as a material event under Regulation 30(4) of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).