Two competing bills introduced last month aim to cut a clear pathway for approval of generic biologic drugs and to save patients and insurers billions of dollars by offering cheaper generics. Gaining consensus on generic biologics will likely not enjoy the broad support of embryonic stem cell research. Fierce debate looms on how long the original maker of the biologic should be granted patent exclusivity. Prospective manufacturers of generic versions are backing one bill that sets the basic exclusivity period at five years, while the other — supported by developers of original biologics — calls for a minimum of 12. Unlike regular medications, generic versions of biologics — often called follow-ons, biogenerics or biosimilars — have no practical regulatory pathway for approval.
"While we are disappointed the C-08 study did not meet its primary endpoint, our initial review of the data leads us to continue to believe Avastin may be active in patients with early-stage colon cancer and look forward to NSABP's presentation at ASCO," said Hal Barron, M.D., senior vice president, Development and chief medical officer, Genentech. "We remain fully committed to the ongoing Avastin adjuvant programs in early-stage colon, breast and lung cancers."
Bevacizumab Study in Early-Stage Colon Cancer Misses Primary Endpoint – OncologySTAT
Genentech, Inc., announced today that the National Surgical Adjuvant Breast and Bowel Project (NSABP) C-08 study did not meet its primary endpoint of improved disease-free survival (DFS) with adjuvant use of bevacizumab (Avastin®) plus chemotherapy in patients with early-stage colon cancer. This was based on results from the final analysis of the NSABP C-08 study, a randomized multinational phase III study designed to evaluate the efficacy of adjuvant 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX), with or without bevacizumab, in patients with resected stage II or III adenocarcinoma of the colon. Bevacizumab is already approved by the US Food and Drug Administration for the treatment of metastatic colorectal cancer. This is the first phase III study of bevacizumab in early-stage disease.