EMA Committee Recommends Marketing Approval For Biocon Biologics & Viatris Biosimilar Bevacizumab

EMA Committee Recommends Marketing Approval For Biocon Biologics & Viatris Biosimilar Bevacizumab

By, Admin 2 March 2021

Biocon Biologics has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization of their 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 authorization in the 27 European Union (EU) member countries and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. For the UK, the Medicines and Healthcare Products Regulatory Agency’s ‘reliance procedure’ will be followed, and the UK marketing authorization 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, bBevacizumab, is a recombinant “humanized” monoclonal antibody that selectively binds to human vascular endothelial growth factor (VEGF) and neutralizes its biologic activity. Bevacizumab inhibits the formation of tumor vasculature, thereby inhibiting tumor growth.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!