Earlier this month, Novartis Zarxio was the first biosimilar product approved in the United States, ushering in a new era for the drug industry, consumers and third parties who manage medical and drug benefits. The introduction of cheaper alternatives to relatively complex biologic drugs has created confusion over the U.S. Food and Drug Administrations approval process and specialty-related product availability to be used or marketed.
Seen as a potentially less expensive alternative to Amgens Neupogen®, which boosts white blood cells to reduce infections in cancer patients, Zarxio is a biosimilar. Biosimilars are versions of biologics that are sufficiently similar to the more costly biologic drug, but not an identical match, as in the case of generics. Biosimilars are regarded as not having meaningful clinical differences with the brand-name biologic drugs they resemble.
