In a precedential decision last week, the U.S. Court of Appeals for the Federal Circuit held that the use of IPR proceedings for patents issued prior to the enactment of the America Invents Act (AIA) was not an unconstitutional taking under the Fifth Amendment to the U.S. Constitution. In that July 30,…
Today, June 28, 2019, the FDA approved Pfizer’s aBLA for ZIRABEV (bevacizumab-bvzr), a biosimilar of Genentech’s AVASTIN. According to its approved package insert, ZIRABEV is indicated for the treatment of metastatic colorectal cancer in combination with certain types of chemotherapy as described on the label. ZIRABEV is the twenty-first biosimilar…
Below is a summary of recent updates on clinical studies involving bevacizumab and infliximab biosimilars. Bevacizumab: China-based Innovent Biologics announced last week that IBI305, a potential biosimilar to bevacizumab, met pre-defined primary endpoints in two clinical trials against branded bevacizumab. One trial was a phase III clinical trial that compared…