In a move that may have significant implications for health care costs, Sandoz has asked the US Supreme Court to resolve a contentious dispute over a rule for launching biosimilars. Specifically, Sandoz wants the court to decide when a drug maker that wants to sell a biosimilar medicine must give notice to the manufacturer of the brand-name version about its product launch.
At issue is the ability of brand-name drug makers to delay the introduction of biosimilars, which are highly identical versions of expensive biologics. And a great deal is at stake for patients, payers, and drug companies because biosimilars are forecast to save an estimated $44 billion in US health care costs over the next decade. Most analysts and payers forecast that biosimilars will cost 10 percent to 30 percent less than the brand-name biologics.
Sandoz, which is the generic unit of Novartis (NVS), hopes to resolve a legal battle that has been under way concerning the notice that a brand-name company is entitled to receive.
A federal law known as the Biologics Price Competition and Innovation Act says that a company seeking to sell a biosimilar must give the manufacturer of the brand-name biologic at least 180-days notice before selling its drug (see page 10). The idea is to allow a brand-name company time to determine what, if any, patent challenges can be pursued, which might further delay a biosimilar launch.
In dispute is when the clock on the 180-day notice starts ticking.
In a complicated and closely watched case last year, Sandoz won the right to sell Zarxio, which is a version of Amgen’s Neupogen, a treatment used to boost white blood cell counts in chemotherapy patients and others with compromised immune systems. But the company lost a key argument over the timing for the notice that it was required to provide Amgen (AMGN).
Sandoz contended the law allowed it to give Amgen notice of its marketing plans 180 days before winning Food and Drug Administration approval for its biosimilar. But a federal appeals court last summer ruled that biosimilar companies must wait until they actually receive FDA approval before they should give brand-name rivals notice of their product launch.
And 180 days can make a big difference, experts say.
“This is a widely debated issue,” said Robert Cerwinski, a partner at the Goodwin Procter law firm, which represents drug makers that sell biologics and are developing biosimilars, and a coauthor of The Big Molecule Watch Blog. In effect, the difference in timing is a valuable right for biosimilar makers and a valuable impediment for brand-name companies.
As noted, Sandoz is already selling its biosimilar, but if the appeals court ruling is allowed to stand and serve more broadly as a benchmark, this interpretation would give brand-name drug makers an important lift. How so? They already have 12 years of exclusivity for their biologics and would have still more time in which to prepare patent challenges for delaying biosimilar launches.
And “the importance (surrounding the debate) is heightened because most of the current (legal) challenges involve biologics that were approved by FDA 12 or more years ago, so the exclusivity period (for these drugs) under the law has expired or is about to (do so) shortly,” said Tom Wintner, a partner at the Mintz Levin law firm, who specializes in patent litigation and pharmaceutical matters.
For the moment, the appeals court ruling also dealt a setback to consumers, since they will have to wait longer before gaining access to lower-cost biosimilars. As Sandoz noted in its petition to the Supreme Court, the Congressional Budget Office had estimated, at the time the law was introduced in 2007, that biosimilars would have reduced total spending on biologics in the US by about $25 billion from 2009 through 2018.
Whether the Supreme Court decides to hear the case is uncertain. One line of thinking is that the justices may prefer to let the lower courts rule on some of the pending cases before wading in to offer a final interpretation. However, one attorney suggested the Supreme Court may agree to review the petition because the lower courts are applying the appeals court ruling and, meanwhile, health care costs are at stake.
“The decision postpones the market entry of approved biosimilar products, in effect delaying the availability of less expensive biosimilar products that the BPCIA was enacted to provide,” said Courtenay Brinckerhoff, a partner and intellectual property lawyer at Foley & Lardner. “It could keep a presumably less expensive product off the market for six months.”