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Agency Opens Doors for Copycat Biotech Drugs

The FDA is examining whether it has the authority under federal law to approve generic versions of biotechnology drugs, according to FDA Commissioner Mark McClellan, MD, PhD. McClellan believes that it may be justifiable for regulators to approve generic forms of biotech drugs even if they have not gone through the same lengthy process required of original drugs.

Biotech drugs are typically defined as laboratory-altered forms of naturally occurring proteins administered by injection or intravenous infusion. They are hard and costly to manufacture, and similar versions of the same protein made by different companies can have slight differences.

Over the years, the FDA has, however, approved copycat versions of standard synthetic "small molecule" drugs that usually come in pill form. Patents on human growth hormone and laboratory-altered insulin, among other older biotech drugs, will start lapsing in the next few years. As a result, officials of generic drugmakers are aggressively seeking the right to then sell their own less expensive copycat forms.

Before moving forward, the FDA soon plans to share its thoughts on the issue and to seek public comment on whether copycat biotech drugs should be approved and under what conditions, the commissioner said. "We definitely will have more to say in the coming months because this is an important issue from the standpoint of innovation and affordability of safe drugs," said McClellan.

Officials of generic drug manufacturers do not take issue with conducting small trials to verify that their products are safe and effective and have the same physical traits as original branded medicines. They claim, however, that they should not have to duplicate the lengthy and expensive trials conducted by the original drugmaker. Although McClellan can sympathize with their argument, he said that the generic biologics should be looked at individually, depending on the complexity of the particular protein.