The Supreme Court of the United States ruled in favor of Sandoz, on Monday, by allowing biosimilars to give notice of commercial marketing before or after FDA approval-meaning biosimilar products can be available sooner.
The Supreme Court of the United States ruled in favor of Sandoz, on Monday, by allowing biosimilars to give notice of commercial marketing before or after FDA approval—meaning biosimilar products can be available sooner.
The unanimous, 9-0 ruling revoked an appeals court decision that restricted Sandoz from selling Zarxio, the biosimilar of Amgen’s Neupogen, which boosts white blood cell counts in cancer patients and costs 15% less than Neupogen. Justice Clarence Thomas delivered the Court’s opinion with Justice Stephen Breyer filing a concurring opinion.
Amgen filed the original lawsuit against Sandoz claiming that Sandoz did not offer a manufacturing or patent notice prior to launching its biosimilar. According to the Court’s ruling, Sandoz did not infringe on Amgen’s patent when it failed to disclose its application and the manufacturing information.
The Affordable Care Act called for biosimilar manufacturers to give name-brand manufacturers a 180-day notice before launching. However, a 2015 ruling by the Circuit court, called for a 180-day marketing notice only after FDA approval. This was also rejected by Thomas in Monday’s ruling, as Sandoz pointed out the additional 6-months of market exclusivity it provides Amgen.
The Circuit court had also ruled that the biosimilar must be licensed at the time that the biosimilar’s maker gives notice. But the justices of the Supreme Court disagree with that ruling.
“The applicant must give ‘notice’ at least 180 days ‘before the date of the first commercial marketing,’” Thomas wrote. He clarified that the wording in the statue of the Biologics Price Competition and Innovation Act is that the biosimilar only needs to be licensed on the “date of the first commercial marketing.”
“Accordingly, the applicant may provide notice either before or after receiving FDA approval,” the justices concluded.
This Supreme Court decision influences the pharmaceutical industry through limiting the amount of time brand-name drug makers can keep biosimilars off the market and therefore offer it consumers more drug options at lower costs.
“The Justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments,” Carol Lynch, the Global Head of Biopharmaceuticals at Sandoz, said in a statement in response to the Supreme Court decision. “We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward. As the global leader in biosimilars, it is our responsibility to help eliminate barriers so patients can access more affordable medicine.”