Health insurers and patients could get a bit of relief after years of paying more and more for biologic speciality pharmaceuticals, but some think there are still barriers to affordability.
The Food and Drug Administration has approved the country's first biosimilar drug, Zarzio, a version of the drug filgrastim (sold as Neupogen by Amgen) that's used to boost white blood cells and prevent infections in cancer patients receiving chemotherapy.
Made by Novartis subsidiary Sandoz, Zarzio is the first biosimilar medicine approved in the U.S. under a pathway created by the Affordable Care Act's Biologics Price Competition and Innovation provisions.
"Biosimilars will provide access to important therapies for patients who need them," said FDA Commissioner Margaret Hamburg, MD. "Patients and the healthcare community can be confident that biosimilar products approved by the FDA meet the agency's rigorous safety, efficacy and quality standards."
The approval is a watershed moment in the country's pharmaceutical history, bringing a system akin to generics to high-priced biologic medicines. Drug benefit management giant Express Scripts estimates that U.S. insurers, patients and taxpayers could save as much as $250 billion through 2024, even if just 11 of the likeliest biosimilars are approved.
But the pace of biosimilar approval remains to be seen, along with the level of opposition from drugmakers and the classification decisions by regulators. Biosimilars are technically are not identical alternatives like generic chemical drugs, since they are derived from living organisms--glycoproteins in the case of filgrastim.
The FDA opted to classify Zarzio as a biosimilar, not as a fully "interchangeable product. That leaves Zarzio ineligible to be automatically substituted for the reference product, Neupogen, without the intervention of the prescribing provider.
Leaders at Prime Therapeutics, the nonprofit pharmacy benefits manager owned by Blue Cross insurers, also have concerns about the feasibility and incentives for drug makers to create biosimilar versions of speciality medicines.
A study commissioned by Prime estimates that biosimilars may only be viable for drugs that can bring in around $900 million, or maybe more.
"While we will see some immediate savings from biosimilar blockbusters that have been used for a decade in Europe, our big concern is that a robust biosimilar market will never exist in the U.S. because many biologics being developed today won't meet the desired sales thresholds," said Peter Wickersham, senior vice president for integrated care and specialty at Prime. "As a result, taxpaying citizens will end up saving less than they could have," and "we will miss the full opportunity biosimilars can yield as one way to help solve the unsustainable growth in healthcare costs."
Even before the first FDA approval, a number of states have considered enacting requirements that prohibit the use of biosimilars, like Zarzio, that are not classified as interchangeable, and various approval processes for pharmacists, plans and physicians to switch to biosimilars.
Then there is the issue of clinical nomenclature. For Zarzio, the FDA designated a "placeholder nonproprietary" name, "filgrastim-sndz."
"While the FDA has not yet issued draft guidance on how current and future biological products marketed in the United States should be named, the agency intends to do so in the near future," regulators wrote. "The provision of a placeholder nonproprietary name for this product should not be viewed as reflective of the agency's decision on a comprehensive naming policy for biosimilar and other biological products."