(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.

“When it comes to getting new biosimilar products on the market, the FDA has taken an innovative approach in supporting their development at every step of the process,” says Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “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.”

The Patient Protection and Affordable Care Act, signed into law by President Obama on March 23, 2010, amended the Public Health Service Act to create an abbreviated approval pathway—under section 351(k)—for biological products that are demonstrated to be highly similar (biosimilar) to, or interchangeable with, an FDA-licensed biological product.

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