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Biocon Biologics Ltd (a subsidiary of Biocon Ltd ) has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation of its biosimilar Bevacizumab, co-developed with Viatris, to be marketed as Abevmy (injection bevacizumab 100mg and 400mg).
Abevmy 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.
The decision of the European Commission (EC) is expected in May 2021, which, when approved, will grant marketing authorisation in the 27 European Union (EU) member countries and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.
Also read: Biocon Biologics, Viatris gets European Commission nod for co-developed diabetes drug
For the UK, the Medicines and Healthcare Products Regulatory Agency’s ‘reliance procedure’ will be followed, and the UK marketing authorisation can be expected shortly after the EC decision.
Kiran Mazumdar-Shaw, Executive Chairperson, Biocon Biologics, said, “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 the 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.”
Abevmy, Bevacizumab, is a recombinant “humanised” monoclonal antibody that selectively binds to human vascular endothelial growth factor (VEGF) and neutralises its biologic activity. Bevacizumab inhibits the formation of tumour vasculature, thereby inhibiting tumour growth.
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