The FDA on Sept. 14, 2017 approved MYASI® (Bevacizumab-awwb) as a Biosimilar to AVASTIN® (Bevacizumab). MYASI® is the first Biosimilar approved in the U.S. for the treatment of cancer. A Biosimilar must show that it has no clinically meaningful differences in terms of safety and effectiveness from the already approved biological product (also known as reference product). A Biosimilar product can only be approved by the FDA if it has the same mechanism of action, route of administration, dosage form and strength as the reference product, and only for the indications and conditions of use, that have been approved for the reference product. The approval of MYASI® was based on comparisons of extensive structural and functional product characterization, animal data, human PharmacoKinetic and pharmacodynamic data, clinical immunogenicity, between MYASI® and AVASTIN® (Bevacizumab), and it was noted that MYASI® is highly similar to AVASTIN® and that there are no clinically meaningful differences between the two products.