FDA Regulation of Biologic Drugs

Over the past several years, a new class of protein drugs has emerged termed ‘biologics’.  These protein or antibody drugs have the potential to treat diseases like cancer.  Products are already on the market to treat arthritis and anemia.

These drugs are very expensive to develop, leading to a high cost for the consumer.  Generic drugs could help reduced costs, but there are questions about how to evaluate these ‘biosimilars’.  Since biologic drugs are extremely complex and can be influenced by subtle changes in manufacturing, a protein produced by a different company could have a different level of effectiveness or adverse side effects.

The Food and Drug Administration (FDA) is in the process of creating guidelines for testing biosimilars.  But there is debate about the right balance between making sure drugs are safe and making the evaluation cost effective.  Should biosimilars be required to go through clinical trials, which are not required for generic chemical drugs?  Or are structural/purity evaluations sufficient to determine safety and efficacy?  The balance between cost and safety, regulation and speed to market, are likely to become even more prevalent as more biologic drugs come to market in the near future.


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