The first biosimilar medication approved for use in the U.S. made its way to the market on Thursday, ushering in a new era of competition between such drugs and the original high-cost biologic therapies they emulate.
Sandoz's drug Zarxio, a biosimilar alternative to Amgen's anti-infection drug Neupogen, will be sold with a wholesale price of $275.66 for a single 300 microgram syringe and at $438.98 for a 480 mcg dose, according to a company spokeswoman. The price reflects a 15% discount from the current price of Neupogen, which costs $324.30 for 300 mcg and $516.45 for 480 mcg doses.
Sold in Europe since 2006, Zarxio was approved by the Food and Drug Administration in March.
Its introduction to the market, along with the possibility of several other biosimilars currently under review joining it, leads many to hope that a competitive, less-expensive market is on the horizon.
Certainly, companies such as Amgen and AbbVie, which rely heavily on biotech drugs and make some of the most expensive drugs on the market, are closely watching these developments.
While generic drugs have been on the market as a cheaper alternative to brand-name chemical medicines for decades, the biosimilar market in the U.S. has been slow compared with other countries. Such copycat biologic products had no pathway for FDA approval before the Biologics Price Competition and Innovation Act.
Leading pharmacy benefits manager Express Scripts estimated in a report released last December that approval of Zarxio could save patients and payers as much as $5.7 billion over the next decade. The report estimated that as much as $250 billion could be saved over the next 10 years if biosimilars for 11 existing biologic drugs make it to market.
Part of the controversy surrounding biosimilars lies in the fact that unlike generics, which are made from the same exact compounds as their brand-name counterparts, alternative biologics are not identical to their reference products since they are derived from living organisms.
That distinction has been the basis of arguments by some—led by biopharmaceutical companies and a number of professional physician organizations - who contend biosimilars should not be treated in the same way as generic products. They say such drugs should carry non-proprietary names that are very distinct from the original biologic to avoid confusion among physicians and pharmacists and prevent adverse reactions.
However, biosimilar proponents, which include patient advocates, insurers and pharmacy benefit managers like Express Scripts, argue biosimilars should carry the same name as their brand-name counterparts in order to lessen confusion about the safety and efficacy of such products.
Last week, the FDA proposed a compromise through guidance that would require both biosimilars and brand-name biologics to carry a four-letter unique suffix on the nonproprietary names they share.
When asked about their position on the FDA's proposed guidance on naming, Sandoz provided the following response:
“We welcome the move by the FDA to provide further clarity with regards to nomenclature of biologics. We continue to believe that the non-proprietary name for Zarxio should be filgrastim, as the existing safety mechanisms in place make a unique non-proprietary name unnecessary.”