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.

“…CuraTeQ Biologics s.r.o., a step-down subsidiary of the Company has obtained marketing authorisation from UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Bevqolva, its bevacizumab biosimilar version,” Aurobindo Pharma said in a regulatory filing.

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.

Article excerpt reposted from CNBCTV18.

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