Human therapeutics company Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) on Thursday jointly announced the receipt of marketing authorisation for MVASI (biosimilar bevacizumab) for the treatment of certain types of cancers from the European Commission (EC).
MVASI is reportedly the first biosimilar bevacizumab approved by the EC. MVASI is a biosimilar to bevacizumab, a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2, thus inhibiting establishment of new blood vessels necessary for the maintenance and growth of solid tumors, added the companies.
The company said MVASI is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum, metastatic breast cancer; metastatic or recurrent NSCLC; metastatic or recurrent non-squamous NSCLC with (EGFR) activating mutations; metastatic renal cell cancer; advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer; as well as persistent, recurrent, or metastatic carcinoma of the cervix.
This EC approved the partnership's MVASI based on a comprehensive data package that demonstrated MVASI and bevacizumab are highly similar, with no clinically meaningful differences in terms of the efficacy, safety and immunogenicity between the products. Clinical studies included results from a Phase 3 trial in patients with non-squamous NSCLC.
In conjunction, the approval of the partnership's MVASI from the EC grants a centralised marketing authorisation with unified labeling in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area, will take corresponding decisions on the basis of the decision of the EC.
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