FDA Releases Guidelines for Generic Biotech Drugs


The FDA has issued guidelines to review generic versions of biotech agents, which are made from biological rather than chemical building blocks.

The FDA has issued guidelines to review generic versions of biotech agents, which are made from biological rather than chemical building blocks.

On February 9, the FDA issued guidelines to review generic versions of biotech agents, such as insulin, vaccines, and a growing number of specialty cancer drugs that are made from biological rather than chemical building blocks.

“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 costs to consumers,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a press release.

Biotech agents, first introduced in the 1980s, have never been exposed to generic competition. The biotech industry has argued that their complex agents—frequently derived from living cells—could not be replicated by competitors. The 2010 Patient Protection and Affordable Care Act, however, required the FDA to develop a system to approve “biosimilar agents.” The term “biosimilar” is used to indicate that these drugs cannot be replicated exactly because they are derived from organisms rather than chemicals.

The draft guidelines allow manufacturers of new biotech agents—known as innovators—to maintain market exclusivity for 12 years. Manufacturers of biosimilar agents will have to submit extensive data to prove that their agent functions similarly to the original, and the FDA will be empowered to request clinical studies when necessary. Human testing will be required in order for the FDA to brand a biosimilar agent “interchangeable” with the original, a designation that would significantly increase the appeal of the biosimilars, with their expected lower price tag, to health care providers and insurers.

The Congressional Budget Office has estimated that purchasing biosimilar agents could save the federal government $25 billion in health care expenditures over the next decade. Biosimilar agents have been available in Europe for several years and typically cost 20% to 30% less than the innovator’s agent.

To learn more, check out our previous coverage of biosimilars:

Biosimilars: Could This Be a Pearl in the Patient Protection and Affordable Care Act? (SpecialtyPharmacyTimes.com, February 10, 2012)

Generic Drugs: Trending Upward in Uncertain Times (Pharmacy Times, 2011 Generic Supplement)

Biosimilars and Health Care Reform (Pharmacy Times, October 2009)

Cheaper Biologics May Soon Be a Reality (Pharmacy Times, April 2007)

EU Generic Firms Respond to “Biosimilar” Criticisms (Pharmacy Times, January 2007)

Ms. Wick is a visiting professor at the University of Connecticut School of Pharmacy and a freelance writer from Virginia.

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