Pharmaceutical companies Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) on Thursday jointly reported the launch of the therapeutic biosimilars MVASI and KANJINTITM in the US oncology market.
MVASI (bevacizumab-awwb) is a biosimilar to Avastin (bevacizumab) and KANJINTITM (trastuzumab-anns) is a biosimilar to Herceptin (trastuzumab). They are the first biosimilar Avastin and Herceptin products to be introduced in the US.
MVASI is a recombinant humanized monoclonal IgG1 antibody that binds VEGF and prevents the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. KANJINTI is a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody.
According to the companies, MVASI is approved by the US FDA for the treatment of five types of cancer: in combination with chemotherapy for metastatic colorectal cancer (mCRC); in combination with chemotherapy for non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; in combination with interferon-alfa for metastatic renal cell carcinoma; and in combination with chemotherapy for persistent, recurrent or metastatic cervical cancer.
KANJINTI is approved by the US FDA for the treatment of all indications of Herceptin: HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
MVASI and KANJINTI were proven to be highly similar to, and to have no clinically meaningful differences in terms of safety and effectiveness from Avastin and Herceptin, respectively, based on a totality of evidence, which included comparative analytical, clinical safety and efficacy data, the companies concluded.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval