U.S. Supreme Court backs quicker approval of drug copies

By Allen Cone  |  June 12, 2017 at 3:44 PM
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June 12 (UPI) -- The U.S. Supreme Court unanimously ruled Monday that biotech drug copies -- called biosimilars -- can become available to consumers quicker.

Writing for the court, Associate Justice Clarence Thomas said that the decision was not based on policy arguments, but rather, the "plain language" of the biosimilar statue itself.

The nine justices overturned a lower court's decision that had prevented Swiss pharmaceutical company Novartis AG from selling its injectable version of California-based Amgen Inc.'s Neupogen until six months after the U.S. Food and Drug Administration approved it.

The 2015 ruling by the U.S. Court of Appeals in Washington, D.C., gave Amgen the extra months of exclusivity on top of the 12 years already provided under the law.

In September 2015, Novartis generic subsidiary, Sandoz, began selling Zarxio, the first biosimilar drug to win U.S. regulatory approval. The drugs boost white blood cell counts in cancer patients to help fight infections.

Sandoz's drug costs about 15 percent less than the brand name. The ruling is predicted to save consumers and insurers billions of dollars, similar to those with generic versions of drugs.

Biologics are made from living cells and cannot be copied exactly to make generic versions. They are are used to treat conditions that include Crohn's disease, ulcerative colitis, rheumatoid arthritis, plaque psoriasis, breast cancer and diabetes.

In a section of the 2010 Affordable Care Act, commonly known as Obamacare, an expedited path for regulatory approval of biosimilars was made that also tried to respect the patent rights of brand-name manufacturers.

The ruling "will help expedite patient access to life-enhancing treatments," Carol Lynch, global head of biopharmaceuticals at Sandoz said in a statement. "We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward."

President Donald Trump has criticized the pharmaceutical industry over pricing practices, promising to encourage competition and bring down drug costs.

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