unlike traditional drugs, biologics aren't vulnerable to generic competition, because the U.S. Food & Drug Administration is still mulling over how to regulate them. So instead of getting exclusive marketing rights for a decade as is the case with many other drugs, manufacturers of biologics get protection indefinitely—or at least until the FDA develops regulations.Importantly, this doesn't mean that they aren't licensed and tested, but that the production and testing of them is significantly different because of their biological starting point. As the FDA states:
Because, in many cases, there is limited ability to identify the identity of the clinically active component(s) of a complex biological product, such products are often defined by their manufacturing processes. Changes in the manufacturing process, equipment or facilities could result in changes in the biological product itself and sometimes require additional clinical studies to demonstrate the product's safety, identity, purity and potency. Traditional drug products usually consist of pure chemical substances that are easily analyzed after manufacture. Since there is a significant difference in how biological products are made, the production is monitored by the agency from the early stages to make sure the final product turns out as expected.
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