U.S. Releases Draft Guidelines for Generic Biologic Drugs
February 16, 2012, 8:03 AM ESTBy Molly Peterson
(Updates with comment from FDA in fourth paragraph.)
Feb. 9 (Bloomberg) -- The U.S. Food and Drug Administration proposed guidelines for approving the first lower-cost copies of biologic drugs derived from living cells.
Regulators will require laboratory and clinical studies to show that the generic versions are “highly similar” to the originals, the FDA said in a draft document posted today on its website.
Generic-drug companies led by Teva Pharmaceutical Industries Ltd. and Novartis AG’s Sandoz division had urged the FDA to create a pathway to start reviewing biosimilars as required by the 2010 health-care law. Access to lower-cost versions of biologic medicines for cancer, arthritis and rare genetic diseases would save $25 billion in a decade, the Congressional Budget Office estimates.
“When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said in a statement.
While low-cost copies of biotech drugs are used in Europe, none has yet been approved in the U.S. The law requires the FDA to establish a review process for the treatments that may save public health programs like Medicare about $7 billion in a decade, according to the Congressional Budget Office.
“These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers,” Woodcock said.
--With assistance from Anna Edney in Washington. Editors: Adriel Bettelheim, Angela Zimm
To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net
To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net
