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Supreme Court Ruling Will Bring Pricey 'Biosimilar' Drugs To Market Faster
Updated June 14, 2017 8:28 AM | Filed under: Health
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(WASHINGTON) - Competitors will be able to take to market more quickly generic copycat versions of pricey blockbuster biologic drugs, including Amgen Inc.'s arthritis and psoriasis medication Humira, the U.S. Supreme Court ruled.

Gary Gately, of Talk Media News ( reports in a unanimous decision, reversing a federal appeals court ruling, the high court said the developer of a copycat "biosimilar" drug would not have to await Food and Drug Administration approval to give branded drugmakers a mandated 180-day "notice of sales."

Consumers hope the competition will bring down the exorbitant prices of drugs such as Humira, which has a list price of about $4,500 for a set of two syringes.

For makers of branded biologic drugs, the decision will mean billions of dollars in lost sales and deprive them of invaluable time to prepare for cheaper generic competition.

Biologic drugs are derived from natural, biological sources such as animals or microorganisms, as opposed to traditional drugs, typically synthesized from chemicals.

The Supreme Court ruling came in a dispute between Amgen and Sandoz, a division of Swiss pharmaceutical giant Novartis that develops biosimilars. A federal appeals court had sided with Amgen, which argued that under the 2009 Biologics Price Competition and Innovation Act, a six-month notice of plans to sell the drug can't start until a biosimilar receives FDA approval.

But Justice Clarence Thomas, who wrote the Supreme Court's opinion, called Amgen's arguments on the meaning of "licensed" in the timetable set forth in the legislation.

"The statute's use of the word 'licensed' merely reflects the fact that, on the 'date of the first commercial marketing,' the product must be 'licensed,' " Thomas wrote. "Accordingly, the applicant may provide notice either before or after receiving FDA approval."

The case involved filgrastim, a biologic Amgen sells under the brand name Neupogen that stimulates production of white blood cells and is used to treat cancer patients undergoing chemotherapy or bone marrow transplants and HIV/AIDS patients, among others.

Novartis's Sandoz division, based in Germany, hailed the decision, saying it will mean patients will get cheaper drugs more quickly.

"The justices' unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments," said Carol Lynch, global head of biopharmaceuticals at Novartis' Sandoz unit. "We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward."

Kelley Davenport, Amgen's corporate affairs director, said in an email to TMN: "While we are disappointed in the Court's decision on the notice of commercial marketing, we will continue to seek to enforce our intellectual property against those parties that infringe upon our rights."

Though a victory for Novartis and other generic biosimilar drug makers, California-based Amgen, the world's largest independent biotechnology firm, also could benefit from the Supreme Court decision.

The company is developing more biosimilars that will likely benefit by not having to abide by the waiting period for notice to market. They FDA recently approved the biosimilar Amjevita, a copycat of Humira, which was second-biggest selling drug in 2015.

Though widely used in Europe, biosimilars remain a new phenomenon in the U.S.: In 2015, filgrastim became the first biosimilar to receive FDA approval.

Under a 2010 law, generic biosimilars can be produced 12 years after the original drug.

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