FDA to Unveil Rules for Reviewing Biosimilars “Very Soon”

Feb 21, 2011   

The U.S. Food and Drug Administration (FDA) will announce new rules for reviewing the first copies of biologic drugs, also known as “biosimilars.” According to FDA Commissioner Margaret Hamburg, these new rules will be formally implemented in “the very near-term time frame.”

The health-care overhaul passed last year included a provision that authorized the FDA to develop a process for approving cheaper copies of compounds made from living cells. The FDA is currently evaluating different models for evaluating that the biosimilars work as well as the products they copy.

In the absence of final rules, generic companies have been filing the same biologics license applications (“BLAs”) used for brand-name drugs. The BLA process does not create savings for patients like the generic drug program for traditional medicines. According to the Congressional Budget Office, it is estimated that Americans would save $25 billion in a decade through rules allowing copies of biologic drugs.

Hamburg stated that the FDA plans to discuss with industry in the next couple of months how much it will charge to review applications for biosimilar products under the new rules. This is a step in the right direction for moving forward with rules for reviewing biosimilars. Fuerst Ittleman will monitor FDAs progress with developing final rules.

For more information on biosimilar products, please contact us at contact@fidjlaw.com.