The FDA Aug. 30 approved Novartis AG's biosimilar version of Amgen's arthritis drug Enbrel.
The product from Novartis's Sandoz unit, called Erelzi (etanercept-szzs), is the third biosimilar drug to receive approval from the Food and Drug Administration. The Affordable Care Act created an abbreviated pathway for the FDA to approve biosimilars. While three biosimilars have been approved, so far the agency hasn't approved any drugs meeting the higher standard of interchangeability.
Sandoz noted in a statement that Erelzi is approved for all indications included in the label of the reference product, Enbrel.
In March 2015, the agency approved Sandoz's Zarxio, a biosimilar of Amgen's cancer treatment Neupogen. In April 2016, the agency approved Celltrion's Inflectra, a biosimilar of Johnson & Johnson's blockbuster arthritis treatment Remicade.
Biological products are generally derived from a living organism, the FDA said. A biosimilar is a biological product that is approved based on a showing that it is highly similar to an already approved biological product and has no clinically meaningful differences in terms of safety and effectiveness from the reference product, in addition to meeting other criteria specified by law.
An interchangeable biological product, in addition to meeting the biosimilarity standard, is expected to produce the same clinical result as the reference product in any given patient, according to the FDA.
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