The Food and Drug Administration is currently mulling the approval process for drugs that are similar to developed biologic drugs. However, the process is complex. Biologic drugs, unlike traditional chemical drugs — such as aspirin — are derived from living cells, which poses difficulties in replicating and reviewing an alternative version of the drug. The copy of the biologic drug is normally dubbed a ‘biosimilar’.
The drug manufacturer, Novartis AG, which may be the first firm to win U.S. approval of a copycat biotechnology drug, paid the RAND Corp. to look at potential domestic savings from the medicines. The RAND study, which was released on Monday, found that the introduction of biosimilar drugs would reduce direct spending on biologics in the U.S. by $44.2 billion from 2014 to 2024.
CQ HealthBeat’s (@CQHealthTweet) Kerry Young reported (subscription) on Monday that FDA is still reviewing comments on the biosimilar drug regulatory process. Separately, a guest opinion in Roll Call on Monday from Marcia Boyle, the chief of an immunodeficiency disease patient group, urged the FDA to carefully consider patient safety concerns since “even a minor difference between a biosimilar drug and the original biologic product, known as its innovator biologic, could have a significant adverse health impact for a patient.”