Supreme Court Ruling Will Speed Biosimilars to Market

Justices overturn six-month waiting period

In a pivotal ruling, the Supreme Court has cut the time it will take for copycat versions of biologic drugs to reach the marketplace, according to a Reuters report. The decision could yield billions of dollars in sales for drug companies.

The justices, in a unanimous 9-to-0 vote, overturned a lower-court decision that had prevented Swiss pharma company Novartis from selling its copycat version of California-based Amgen’s Neupogen (filgrastim) until six months after the FDA approved it.

The dispute involved a section of the Patient Protection and Affordable Care Act (PPACA) that created an expedited path for regulatory approval of biosimilars while respecting the patent rights of brand-name manufacturers.

Novartis argued 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.

Unlike traditional drugs, biologics are made from living cells and cannot be copied exactly to make generic versions. They are used to treat a range of conditions, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, plaque psoriasis, breast cancer, and diabetes.

Novartis unit Sandoz in September 2015 began selling Zarxio (filgrastim-sndz), the first biosimilar drug to win U.S. regulatory approval. Neupogen and Zarxio boost white blood cell counts in cancer patients to help fight infections.

After its launch, Zarxio cost 15% less than Neupogen at list prices, according to Novartis. Sales of Neupogen, meanwhile, dropped from more than $1 billion in 2015 to $765 million last year, primarily because of competition in the United States, the company said in regulatory filings.

Amgen sued Sandoz in 2014 in San Francisco federal court, alleging patent infringement and violations of the PPACA provision governing biosimilars. The companies disagreed on how to apply the PPACA’s requirement that a biosimilar drug maker give the brand-name manufacturer 180 days notice before launching its copycat version.

In July 2015, the appeals court ruled that the 180-day notice must be given after FDA approval. Novartis appealed to the Supreme Court, with the Trump administration backing the company’s arguments.

Source: Reuters (link is external); June 12, 2017.

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