Biosimilars are products that are highly similar to a previously FDA-approved biological product. It gains approval primarily by proving that it is similar yet better than the reference product; that it has no meaningful differences in terms of safety and effectiveness from the reference product.
The case in discussion is centered on an application by Novartis AG’s Sandoz unit to sell a biosimilar of Amgen Inc.’s Neupogen, a white blood cell booster that has been circulated since the year 1991. The biosimilar- Zarxio is claimed to have the same positive effects as that of Neupogen but with a lower cost.
The case which appeared before the U.S. Supreme Court was issued a mixed decision stating that the patent holders cannot use the federal law to pressurize a company seeking to sell “biosimilars” to divulge information regarding their product. However, it also said that patent holders are free to use state laws to accomplish the same goal.
“Payers need every tool in their arsenal to bring cost-effective solutions to market. Express Scripts continues to champion for a clear pathway to expand the appropriate use of biosimilars” said Express Scripts Holding Co., the pharmacy benefit management company, applauding the courts’ decision.
