Supreme Court Ruling Raises Biosimilars’ Access

PBMs and health-care groups praised the recent U.S. Supreme Court decision that is expected to accelerate patients’ access to biosimilar medications.

The ruling in the case, Sandoz Inc. v. Amgen Inc., allows biosimilar manufacturers to give marketing notice before FDA approval so that their products can get to market quicker.

"The Supreme Court’s decision today is a huge victory for American patients and consumers,” said Chip Davis, President and CEO of the Association for Accessible Medicines (AAM). “This ruling will help provide faster access to lower-cost biosimilar medicines for millions of patients facing diseases such as several forms of cancer, rheumatoid arthritis, psoriasis, multiple sclerosis, and other life-threatening conditions.”

 “This ruling should help expand access and lower prescription drug costs for employers, health plans, labor unions, and Medicare,” said PBM Express Scripts in a statement provided to Drug Topics. “At a time when the cost of complex biologic specialty drugs is growing at double-digit rates, 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.”

Novartis’ Sandoz filed the lawsuit against Amgen in 2015, after Amgen moved to block the sale of Sandoz’s biosimilar to Neupogen (filgrastim), a bone marrow stimulant used to treat neutropenia in cancer patients.

Amgen has reason to be concerned about biosimilar competition. Neupogen’s sales plummeted 31% to $148 million in the first quarter of 2017 because of competition from Novartis’s Zarxio, the first biosimilar to Neupogen approved by the FDA, as well as from Granix, manufactured by Teva Pharmaceuticals.

While Amgen argued that the notice to market a biosimilar drug should not happen until FDA approval, Sandoz said that Amgen’s interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) would result in an extra six months of exclusivity for Neupogen, which was not intended by the Act.

In addition to impacting manufacturers making biosimilars to Neupogen, the ruling affects the launch and marketing of future biosimilar medications as well.

The Supreme Court decision allows biosimilar manufacturers to start advertising their drugs before they know what indications the FDA will approve the drug for, rather than waiting for FDA approval to start advertising, said Stacey L. Worthy, Executive Director of Aimed Alliance, a non-profit that aims to improve access to new medicines and technologies.

“We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward,” said Eric Althoff, Director of Global Media Relations for Novartis.

“The Supreme Court said 12 years was long enough for biologics to have a monopoly, and the ruling likely will spur more manufacturers to develop and launch biosimilars without unnecessary delay,” said Bruce A. Leicher, Chair of AAM’s Biosimilars Council and Senior Vice President and General Counsel at Momenta Pharmaceuticals, Inc. “A healthy competitive marketplace keeps the innovation engine of American industry on track.”

While the ruling allows biosimilars to be marketed sooner, it could lead to confusion and improper prescribing if the FDA approves the drug for different indications than what the manufacturer had been advertising the drug for, according to Worthy.