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FDA drafts rules for pharmaceutical sales of generic copy cat drugs

Feb 10, 2012 01:55 PM
The Food and Drug Administration (FDA) has released its long-awaited draft rules for the pharmaceutical sales and development of lower-cost generic biotech drugs.

"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," stated Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. "These draft documents are designed to help [the] 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."

The new approval pathway may not include the full-scale human trials needed by other pharmaceutical sales companies seeking approval of their brand name treatments. Many of those companies argue that human testing on copy cat drugs is necessary before a biosimilar should be marketed for similar use.  The FDA said it will decide on the "extent and scope" of animal and clinical studies after it reviews more analytical data.

According to the market analysis firm Datamonitor, the global market for generic versions of biotech drugs is expected to grow from $243 million last year to $3.7 billion by 2015.

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