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Sanofi chief says US Supreme Court ruling on biologics has "immediate impact"

Reuters Health News Jun 21, 2017

The US Supreme Court decision to speed access to copycat biologics drugs on Monday was expected but has an "immediate impact," Sanofi Chief Executive told Reuters.

The justices, in a 9–0 ruling, overturned a lower court's decision that had prevented Swiss pharmaceutical company Novartis from selling its copycat version of California–based Amgen Neupogen (filgrastim) until 6 months after the US Food and Drug administration approved it.

The decision has major implications for the pharmaceutical industry because it will dictate how long brand–name makers of biological drugs can keep biosimilars off the market.

Even the 6 months at issue in the case can mean hundreds of millions of dollars in sales. Health insurers expect biosimilars to be cheaper than original brands, like generics, saving consumers billions of dollars each year.

"It is something we had to be ready for...it is part of the business model," Olivier Brandicourt said of the announcement, adding the ruling had an "immediate impact."

Brandicourt was speaking to Reuters on the sidelines of the Viva Technology forum in Paris.

Asked if the ruling could modify the company's financial guidance, Brandicourt said Sanofi had not yet had enough time to evaluate its financial consequences.

"As far as we are concerned, we have not yet had sufficient time to evaluate, in the frame of our strategic plan, the possible financial consequences, if they were to be any," he said.

Sanofi is due to publish its half–year results on July 31.

—Matthias Blamont

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