Biocon Biologics Ltd, a subsidiary of Biocon Ltd is one step closer to bagging a marketing approval for its biosimilar cancer drug Bevacizumab in the European Union member countries.
The company said the product received a positive response from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). With the committee recommending the marketing authorisation of Bevacizumab, the company now needs final approval from the European Commission (EC), expected by May 2021.
Co-developed with Viatris, and to be marketed as Abevmy (injection bevacizumab 100mg and 400mg), the drug is a biosimilar to Roche's Avastin, prescribed for all indications including metastatic colorectal carcinoma, metastatic breast cancer, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer as part of a specific regimen.
"CHMP's decision to recommend approval of our biosimilar Bevacizumab brings us a step closer to enable affordable access to this biologic therapy for cancer patients in the EU along with our partner Viatris. It is an outcome of our commitment to expand access for patients leveraging our science and global scale manufacturing for a range of biosimilars. Through bTrastuzumab and bPegfilgrastim we are already making a difference to lives of cancer patients in several EU countries. We look forward to a final decision from the European Commission approving biosimilar Bevacizumab, which will add to our efforts in cancer care," Kiran Mazumdar-Shaw, Executive Chairperson, Biocon Biologics, said
Abevmy is a recombinant 'humanized' monoclonal antibody that selectively binds to human vascular endothelial growth factor (VEGF) and neutralises its biologic activity. It inhibits the formation of tumor vasculature, thereby inhibiting tumor growth, the company said.
Once approved, the product can be marketed in the 27 European Union (EU) member countries and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. The company says that for the UK, the Medicines and Healthcare Products Regulatory Agency's "reliance procedure" will be followed, and the U.K. marketing authorisation can be expected shortly after the EC decision.
Biocon Biologics claims to be a fully integrated 'pure play' biosimilars organisation that leverages cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a platform of 28 biosimilar molecules across diabetes, oncology, immunology, dermatology, ophthalmology, neurology, rheumatology and inflammatory diseases. Five molecules from Biocon Biologics' portfolio have been taken from lab to market, of which three have been commercialised in developed markets like United States, EU, Australia, Canada and Japan.