Supreme Court Ruling Supports Patient Access To Biosimilars

by Crystal Kuntz

June 16, 2017

This week, in a unanimous decision, the U.S. Supreme Court ruled in favor of Sandoz that biosimilar makers can provide their 180-day notice of marketing to branded biologic companies prior to approval of the biosimilar by the Food and Drug Administration (FDA).

Here’s what you need to know about this important ruling:

  • In February, AHIP filed an amicus brief in the case (Sandoz v. Amgen) in support of Sandoz’s position and as part of our ongoing efforts to address the high cost of prescription drugs, including expensive biologics.
  • The ruling removes a key impediment to consumer access to lower cost biosimilars. Lower courts had ruled that biosimilar makers had to wait until after their product was approved by the FDA before they could provide the 180-day notice, which essentially provided branded biologic companies with an additional six months of exclusivity protection from biosimilar competition. The Supreme Court’s ruling will allow for access to biosimilars as soon as they have been approved by the FDA.
  • Expensive biologics continue to jeopardize affordability and blocks significant cost savings that come from access to lower cost biosmilars. For example, in 2014, Medicare spent $21 billion on Part B drugs, which are largely high-cost biologics delivered in hospital outpatient setting or physician offices. Spending for one of these drugs – Remicade – was $1.2 billion in 2014 alone; Remicade is also one of the top selling drugs in the world.
  • In April, the FDA recently approved a second biosimilar to Remicade, the drug Renflexis. The Supreme Court’s ruling helps ensure that patients wont’ have to wait six more months before they can have access to this lower-cost option for their treatment.

AHIP commends the Supreme Court’s ruling, which makes sure patients have to access to affordable, lifesaving biosimilar medicines.

 Crystal Kuntz is Vice President, Policy at AHIP.