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Supreme Court speeds copycat biologic drugs to market

The justices, in a 9-0 ruling, overturned a lower court's decision that had prevented Swiss pharmaceutical company Novartis AG (NOVN.S) from selling its copycat version of California-based Amgen Inc's (AMGN.O) Neupogen until six months after the U.S. Food and Drug Administration approved it.

The dispute involved a section of the 2010 Affordable Care Act, dubbed Obamacare, that created an expedited path for regulatory approval of biosimilars while trying to respect the patent rights of brand-name manufacturers.

Novartis complained that the 2015 ruling by the U.S. Court of Appeals for the Federal Circuit in Washington handed Amgen an extra six months of exclusivity on top of the 12 years already provided under the law.

They are used to treat a range of conditions, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, plaque psoriasis, breast cancer and diabetes.

Amgen sued Sandoz in 2014 in San Francisco federal court alleging patent infringement and violations of the Affordable Care Act provision governing biosimilars.

READ MORE (Reuters)

  • Supreme Court rules to speed marketing of lower-cost 'biosimilar' drugsThe Hill
  • US Supreme Court backs quicker approval of drug
  • The Supreme Court just issued a big win for new drugs that could save the US ...Business Insider
  • US Supreme Court Issues Mixed Ruling on Biotech-Drug CopiesBloomberg
  • US Supreme Court overturns copycat drug delaysRT
  • Supreme Court rules to allow lower-cost biosimilars to market faster in Sandoz ...STAT
  • US Supreme Court: No Six-Month Wait for Biosimilars After FDA ApprovalRegulatory Focus
  • High court ruling speeds up generic biotech drug approvalNew York Daily News
  • US high court speeds copycat biologic drugs to marketNasdaq

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Supreme Court speeds copycat biologic drugs to market


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