Court Supports FDA Approval of Sandoz's Generic Fusilev

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By Dana A. Elfin

June 7 — The FDA scored a victory when a federal appeals court upheld the agency's approval of a generic of Spectrum Pharmaceuticals Inc.'s cancer drug Fusilev ( Spectrum Pharms., Inc. v. Burwell, 2016 BL 176830, D.C. Cir., No. 15-5166, 6/3/16 ).

A three-judge panel of the U.S. Court of Appeals for the D.C. Circuit said June 3 the Food and Drug Administration's decision to approve Sandoz Inc.’s generic version of Fusilev (levoleucovorin) was reasonable.

The panel's ruling is a loss for Spectrum, which wanted the FDA's approval of Sandoz's generic pulled or stayed.

Spectrum has until June 17 to ask the panel or the full appeals court to rehear the case, according to the Federal Rules of Appellate Procedure.

The company didn't respond to a request for comment.

Princeton, N.J.-based Sandoz, part of Swiss company Novartis, welcomed the ruling. “We are pleased with the decision by the federal appeals court to uphold the approval by the FDA,” Leslie Pott, vice president of communications at Sandoz, told Bloomberg BNA June 7.

Financial Implications for Spectrum

The D.C. Circuit's decision is likely to have financial consequences for Spectrum.

Prior to Sandoz's launch of its generic Fusilev product in April 2015, Fusilev sales accounted for the majority of Spectrum's revenues.

According to Bloomberg data, in 2014, branded Fusilev sales were $105.6 million, representing 57 percent of the company's revenues.

In 2015, net sales of Fusilev declined to $60.7 million, presumably reflecting the impact of Sandoz's generic entering the levoleucovorin market. Total product sales for 2015 were $136.9 million, a 27 percent drop from the company's $186.5 million in total product sales for 2014.

Violation of Exclusivity Rights?

Fusilev has seven years of FDA-approved market exclusivity as an orphan drug until April 29, 2018, to treat pain in patients with advanced metastatic colorectal cancer.

Under the Orphan Drug Act of 1983, the FDA can award seven years of marketing exclusivity to reward companies for developing drugs to treat rare conditions and diseases. Rare or “orphan” diseases are defined as those that affect 200,000 or fewer Americans.

Fusilev is also approved for two uses related to counteracting the effects of the cancer drug methotrexate after high-dose therapy for bone cancer, but the orphan exclusivity doesn't apply to those uses.

The FDA approved Sandoz's generic as a “carve-out” generic, meaning not all of the uses listed on the branded drug's label appear on the generic label. Sandoz’s generic drug is labeled for two uses related to counteracting the effects of the cancer drug methotrexate after high-dose therapy for bone cancer but not for the exclusivity-protected colorectal cancer pain indication.

The issue in the case was whether the FDA appropriately approved Sandoz's generic version of Fusilev in the same vial sizes as Spectrum's brand-name drug while allowing the generic drug manufacturer to carve out an exclusivity-protected indication from its labeling.

Spectrum Says Approval Was Illegal

Spectrum argued that the agency's approval illegally sidestepped Spectrum’s seven years of orphan drug exclusivity for the palliative treatment of patients with advanced metastatic colorectal cancer.

Spectrum sued the FDA in the U.S. District Court for the District of Columbia over its decision to approve Sandoz's product on April 27, 2015, three days after Sandoz launched its generic Fusilev product (13 PLIR 611, 5/1/15).

In May 2015, Judge Royce C. Lamberth dismissed Spectrum's lawsuit (13 PLIR 760, 5/29/15). Spectrum, which is based in Henderson, Nev., then appealed the dismissal to the D.C. Circuit (13 PLIR 1539, 10/30/15).

In October 2015, a three-judge panel including Judges Thomas B. Griffith, Brett M. Kavanaugh and Robert L. Wilkins heard oral argument in the case (13 PLIR 1539, 10/30/15).

The panel said the FDA approval of Sandoz's generic didn't violate Spectrum’s orphan drug exclusivity, affirming the district court's earlier decision in the case.

The FDA interpreted the Orphan Drug Act to allow it to approve Sandoz’s generic product as long as the generic label omitted mention of the exclusivity protected-colorectal cancer pain indication. The panel said the FDA's interpretation of the statute was reasonable, and, contrary to Spectrum's arguments, wasn't arbitrary or illegal.

“To the extent FDA has discretion in choosing how best to implement the Orphan Drug Act, it is up to the agency to strike the balance between the congressional policy goals of drug affordability and innovation,” the opinion said.

Griffith wrote the opinion for the panel.

Hogan Lovells US LLP in Washington represented Spectrum.

Hyman, Phelps & McNamara, P.C. in Washington represented Sandoz.

The Department of Justice, Washington, represented the government.

To contact the reporter on this story: Dana A. Elfin in Washington at

To contact the editor responsible for this story: Brian Broderick at

For More Information

A copy of the opinion is available at

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