In a study published in Clinical Therapeutics on April 22, AryoGen Pharmed’s proposed bevacizumab biosimilar, BE1040V (STIVANT), was found to be noninferior to the reference product (AVASTIN) in a Phase III clinical trial in patients with metastatic colorectal cancer. AryoGen Pharmed is a pharmaceutical manufacturer based in Iran that specializes in the development of therapeutic monoclonal antibodies and proteins. The company’s current marketed products include ARYOSEVEN (eptacog alfa), ALTEBREL (etanercept), ZYTUX (rituximab), and ARYOTRUST (trastuzumab).
AryoGen Pharmed has become the first manufacturer of monoclonal antibody (MAb) biologics in the Middle East and North Africa (MENA) region to receive good manufacturing practice (GMP) certification from the European Medicines Agency (EMA).