Aurobindo Pharma Subsidiaries Secure FDA, Health Canada, and EU Biosimilar Approvals and Partnerships

Aurobindo Pharma and its subsidiaries have secured multiple regulatory approvals and a major European distribution agreement across its biosimilar and dermatology pipelines in recent months, spanning Health Canada, the US FDA, and the European Union.

CuraTeQ Biologics, Aurobindo Pharma's biosimilars-focused arm, has received a notice of compliance (NOC) from Health Canada's Biologics and Radiopharmaceutical Drugs Directorate for its bevacizumab biosimilar Bevqolva, indicated in the treatment of different types of cancer. Health Canada issues an NOC after a successful review, granting formal marketing authorisation to the biosimilar by confirming it meets regulatory standards for safety, efficacy, and quality — comparable to the reference biologic drug under the Food and Drug Regulations. Bevqolva is available in 100 mg and 400 mg formulations; the originator product Avastin is marketed by Roche/Genentech. Bevacizumab, a humanised monoclonal antibody, inhibits the formation of new blood vessels and slows tumour vascular growth and treats multiple cancers, including colorectal and lung. CuraTeQ Biologics also has two additional biosimilar applications under review by Health Canada.

Separately, CuraTeQ Biologics has entered into a definitive marketing and distribution agreement with European healthcare company STADA Arzneimittel AG for two biosimilars that have already received approval from the European Medicines Agency (EMA). The initial focus for distribution will be key markets within the European Union, specifically France and Germany. New brand names will be created and registered for each biosimilar product in these territories.

In the dermatology space, Acrotech Biopharma Inc., a wholly owned step-down subsidiary of Aurobindo Pharma Limited, received US FDA approval on February 13, 2026, for ADQUEY (difamilast 1%) ointment to treat mild-to-moderate atopic dermatitis in adults and pediatric patients aged 2 and older. ADQUEY is a novel, non-steroidal, topical phosphodiesterase 4 (PDE4) inhibitor developed in collaboration with Otsuka Pharmaceutical Co., Ltd., which discovered and developed difamilast and licensed it to Acrotech in the United States since 2021. The FDA approval was supported by multiple studies including pivotal Phase III controlled trials, which demonstrated that a significantly greater proportion of patients treated with ADQUEY achieved Investigator's Global Assessment (IGA) success compared to vehicle (placebo) after four weeks of treatment. The most common adverse reaction was nasopharyngitis at 6%; less common adverse reactions (less than 1%) included application site folliculitis, contact dermatitis, application site rash, and molluscum contagiosum.