Bevqolva (bevacizumab biosimilar) / Aurobindo, CuraTeQ Biologics - LARVOL DELTA

Aurobindo Pharma announced that CuraTeQ Biologics…announced that the Central Drugs Standard Control Organization (CDSCO) has granted Marketing Authorisation under Form CT 23 for Bevqolva, a bevacizumab biosimilar indicated for metastatic carcinoma of the colon or rectum (Business Standard) - "The authorisation permits manufacture at CuraTeQ's facility in Hyderabad and marketing of Bevqolva in 100 mg/4mL and 400 mg/16 mL vial presentations."

Approval • Colon Cancer • Rectal Cancer

Aurobindo Pharma on Friday said its arm CuraTeQ Biologics has received a compliance notice from Health Canada's Biologics and Radiopharmaceutical Drugs Directorate for its bevacizumab biosimilar Bevqolva, indicated in the treatment of different types of cancer. (The Economic Times) - "Health Canada issues an NOC (notice of compliance) 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, Aurobindo Pharma said in a regulatory filing."

Canada approval • Oncology

Aurobindo Pharma arm secures UK MHRA approval for bevacizumab biosimilar Bevqolva (CNBC-TV18) - "Drug maker Aurobindo Pharma Ltd on Saturday (December 21) said its step-down subsidiary CuraTeQ Biologics s.r.o. has received marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Bevqolva, its biosimilar version of bevacizumab....Bevqolva 25 mg/mL concentrate for infusion will be available in 4 mL (100 mg) and 16 mL (400 mg) single-use vials for infusion into veins....Bevacizumab is used in the treatment of multiple cancers including metastatic colorectal cancer, recurrent or metastatic non-squamous non-small cell lung cancer, advanced and/or metastatic renal cell carcinoma, cervical cancer and epithelial ovarian, fallopian tube and primary peritoneal cancer."

MHRA approval • Cervical Cancer • Colorectal Cancer • Fallopian Tube Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma