More affordability may be coming to the surging speciality pharmaceuticals space, as regulators move to approve the first generic-equivalent version of a biologic drug.
An oncology advisory panel of the Food and Drug Administration has recommended approval of Novartis' biosimilar version of the drug filgrastim, sold as Neupogen by Amgen, used to boost white blood cells and prevent infections in chemotherapy patients.
If the FDA follows the recommendation of its Oncologic Drugs Advisory Committee, the Novartis medicine will be the first biosimilar drug approved in the U.S. under the pathway outlined in the Affordable Care Act, the Biologics Price Competition and Innovation Act.
The process for biosimilars may not be speedy, however, as regulators debate how to apply the generic framework to biologic drugs, which technically are not identical alternatives like generic chemical drugs since they are derived from living organisms (glycoproteins in the case of filgrastim).
For payers, though, the introduction of biosimilars could help temper costs for speciality drugs, one of the fastest growing areas of healthcare spending. Drug benefit management giant Express Scripts estimates that U.S. insurers, patients and taxpayers could save as much as $250 billion through 2024 if even just 11 of the likeliest biosimilars are approved.
That's a very optimistic projection, according to others. Analysts at the Rand Corporation think the savings in the U.S. would be closer to $50 billion over the next decade.
Either way, biosimilars are already offering other countries cost savings, without any safety issues, Express Scripts noted in a research brief. The European Union first started using biosimilars in 2006, approving more than 20 since then. Australia and Canada enacted biosimilar pathways in 2010.
Globally, nine versions of filgrastim are marketed by nine different companies. Zarzio, the brand name for Novartis's version, sold through its subsidiary Sandoz, is available in 40 countries. In the U.S. the biosimilar could put price pressure on Amgen's Neupogen, which garnered more than $1 billion in annual sales in 2013.
Reviewing a range of evidence, the FDA committee concluded that there are "no clinically meaningful differences between" EP2006, the designation for Zarzio, and Neupogen, used as the reference product under the biosimilars pathway.
"We are pleased with the (committee's) recommendation to approve our biosimilar filgrastim and we look forward to continuing to work with FDA as it completes its review of our filing," said Mark McCamish, MD, head of global biopharmaceutical and oncology injectables development at Novartis' Sandoz. "We are proud to lead the way in biosimilars globally and believe this positive recommendation brings us one step closer to delivering high-quality biosimilars to patients in the U.S."
The FDA committee recommended approval of the biosimilar for all of the same five conditions allowed for Neupogen: to reduce infections associated with cancer treatment and to reduce fever, to increase white blood cell recovery in acute myeloid leukemia chemotherapy, to reduce low-white blood cell count in bone marrow transplant patients, and to mobilize cells in leukapheresis.