US Supreme Court speeds copycat biologic drugs to market
US Supreme Court speeds copycat biologic drugs to market
12 Giugno, 2017, 22:28
Manufacturers of copycat "biosimilar" medical products will be able to bring their drugs to the market faster after a unanimous U.S. Supreme Court decision Monday.
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 unit Sandoz in September 2015 began selling Zarxio (filgrastim-sndz), the first biosimilar drug to win USA regulatory approval.
Lawyers for Sandoz had argued that Congress clearly never meant to provide bonus time to the 12 years of marketing exclusivity provided by the law. But while they've helped advance disease treatments, they can be expensive.
Unlike traditional drugs, biologics are made from living cells and can not be copied exactly to make generic versions.
Rising drug prices are a matter of concern for patients and policymakers. Neupogen and Zarxio boost white blood cell counts in cancer patients to help fight infections.
Sandoz launched filgrastim-sndz in fall 2015 at a list price of 15% less than that of filgrastim.
Amgen sued Sandoz in 2014 in San Francisco federal court, alleging patent infringement and violations of the PPACA provision governing biosimilars. Sales of Neupogen, meanwhile, dropped from more than $1 billion in 2015 to $765 million previous year, primarily due to competition in the United States, the company said in regulatory filings.
That marked a clear win for Sandoz, the big Novartis generics unit which is fielding a full slate of these copycat biologics. In a 2015 decision, the appeals panel ruled that Sandoz was required to share its abbreviated biologics license application (aBLA), and could provide marketing notice only after its biosim won FDA approval.
The companies disagreed on how to apply that law's requirement that a biosimilar drug maker give the brand-name manufacturer 180 days notice before launching its copycat version.
Justice Clarence Thomas delivered the high court's opinion, in which he wrote that Amgen's "unpersuasive" arguments "cannot overcome the statute's plain language".
In July 2015, the appeals court ruled that the 180-day notice must be given after FDA approval, a ruling the Supreme Court reversed on Monday.
The Trump administration had backed Novartis' arguments in the case.
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