A unanimous U.S. Supreme Court has handed biosimilar developers a key victory that could generate millions in future sales by ruling that they can bring their treatments to market upon FDA approval without waiting an additional six months.

The High Court yesterday ruled in favor of Novartis’ Sandoz unit by reversing a decision by the U.S. Court of Appeals for the Federal Circuit (CAFC). The CAFC decision forced Sandoz to wait 180 days before it could launch Zarxio® (filgrastim-sndz)—its biosimilar version of Amgen’s leukocyte growth factor Neupogen® (filgrastim).

Zarxio gained the FDA’s first-ever approval of a biosimilar in March 2015, and it was launched in September of that year, indicated for five of Neupogen’s six indications.

“The Justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments,” Novartis said in a statement. “Biosimilars offer significant value to patients, providers, and payers, increasing the number of treatment options available to patients across many disease areas at a reduced cost to the healthcare system.”

Zarxio is part of Novartis’ biopharmaceuticals segment, which generated $1 billion in global sales last year, up 31% from 2015, the pharma giant stated in its 2016 annual report.

Novartis does not break down sales of Zarxio or any other biosimilar within the segment, spokesman Eric Althoff told GEN. The segment includes Glatopa® (glatiramer acetate injection), the first FDA-approved generic version of Teva Pharmaceutical Industries’ multiple sclerosis treatment Copaxone® (glatiramer acetate injection).

180-Day Provision

At issue in the case was how to interpret a provision of the Affordable Care Act (“Obamacare”) that was intended to speed up FDA review of new biosimilar applications while respecting the patent rights of branded drug developers. The provision—known as the Biologics Price Competition and Innovation Act (BPCIA)—requires biosimilar drug developers to give reference drug makers 180 days’ notice that they will launch a biosimilar version.

In 2015, the CAFC ruled that biosimilar developers must give the 180-day notice after FDA approval—a decision reversed by the Supreme Court, which held that the additional time amounted to six extra months of exclusivity on top of the 12 years granted to reference drug developers under the BPCIA.

“The Federal Circuit erred in issuing a federal injunction prohibiting Sandoz from marketing Zarxio until 180 days after licensure,” the Court stated in its opinion, written by Justice Clarence Thomas and filed yesterday. “Amgen’s contrary arguments are unpersuasive, and its various policy arguments cannot overcome the statute’s plain language.”

The court also ruled as unenforceable a provision of the BPCIA requiring biosimilar applicants seeking FDA approval to provide its application and manufacturing information to reference-drug sponsors within 20 days of notification by the agency that it accepted the application for review. The resulting exchange of information sets the stage for both companies to decide on patents to be resolved through both immediate and long-term litigation.

However, the Supreme Court said the CAFC, upon being remanded the case, should determine whether such a provision could be enforced through state law, as Amgen argued could be done in California.

“For both innovators and biosimilar applicants, increased certainty should be welcome,” said Margaret Bolce Brivanlou, Ph.D., a partner with the law firm King & Spalding. “The relatively new statute is complex, and many aspects of it open to interpretation and recent litigation. What’s at stake is how soon a biosimilar can come on the market after FDA approval.”

Amgen sued Sandoz in 2014 in U.S. District Court in San Francisco, alleging that the Novartis unit infringed its patent for Neupogen and violated the Affordable Care Act provision governing biosimilars.

Amgen contended that Sandoz and other biosimilar developers had to wait 180 days from FDA licensure before launching biosimilar drugs. Amgen spokeswoman Kelly Davenport told Reuters the company was disappointed in the High Court decision but “will continue to seek to enforce our intellectual property against those parties that infringe upon our rights.”

Zarxio is indicated for patients with cancer receiving myelosuppressive chemotherapy, patients with acute myeloid leukemia receiving induction or consolidation chemotherapy, patients with cancer undergoing bone marrow transplantation, patients undergoing autologous peripheral blood progenitor cell collection and therapy, and patients with severe chronic neutropenia.

The only Neupogen indication not covered by Zarxio is increasing survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation sickness).

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