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Regulations governing biologics are evolving rapidly

Posted by Smiley & Smiley on Jan 15, 2015 6:14:23 PM

The science of medicine is constantly evolving. Sometimes areas of this particular science evolve more rapidly at others. Currently, the science of medications is evolving at a rapid pace. One of the most significant developments to occur in medication-related science over the past several years is the prevalence of biologic drugs in the marketplace.

According to, a biologic drug, “is manufactured in a living system such as a microorganism, or plant or animal cells. Most biologics are very large, complex molecules or mixtures of molecules.” Because biologics are manufactured in this specific way, they are generally regulated differently than non-biologic drugs are. These differing regulations help to ensure that patients are not subjected to serious injuries and even death as a result of taking either form of medication.

However, it seems that regulations related to biologic drugs are evolving as well. Specifically, the Food and Drug Administration is broadening the ability patients to access affordable biologic drugs. According to The New York Times, biologic drugs are among the most expensive medications on the market today. But because these drugs are so specific, some patients cannot use alternatives, even if they cannot afford the biologic drugs they need.

An expert panel recently recommended that the FDA approve a generic copy of a very expensive biologic drug used in cancer treatment. If the FDA ultimately approves this generic biologic, patients may be granted access to a host of cheaper, generic versions of these kinds of drugs. As long as the FDA takes steps to ensure the safety of generic biologics, this particular development could be a most welcome one.

Source: New York Times, “For First Time, F.D.A. Panel Approves Generic Copy of Costly Biologic Drug,” Sabrina Tavernise, Jan. 7, 2015

Topics: defective-products


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