On April 15, 2015, CMS issued a preliminary recommendation for a HCPCS code for Zarxio, the first biosimilar product ever to be approved by the FDA. CMS’s recommendation provides the first indication of how the agency will establish HCPCS codes for biosimilars that are not interchangeable with the reference products they are based on, and also has significant implications for how such biosimilars will be reimbursed under Medicare Part B.

Background on Biosimilars -

A similar biologic medicinal product, commonly referred to as a biosimilar, is a copy of an approved original biologic medicine whose data protection has expired. The relationship of biosimilars to the original biologic medicine is like the relationship of a generic to a brand name drug but not exactly the same as biosimilar, as the name implies, are similar to but not exact copies of the original product. Because biologicals are derived from living cells or organisms and consist of relatively large and often highly complex molecules, the biosimilar cannot be entirely identical to the original biologic, also referred to as the reference product. FDA approved the first biosimilar, Zarxio on March 6, 2015, a biosimilar of the biologic reference product, Neupogen, active ingredient filgrastim.1 As part of the approval, FDA also gave Zarxio a temporary name, filigrastim-sndz, composed of the name of the biologic and a modifier identifying the manufacturer, Novartis (Sandoz).