Lunedi, 20 Mag, 2019

US Supreme Court speeds copycat biologic drugs to market

Endpoints News Endpoints News
Sveva Terracina | 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.

Consigliato

  • Guterres calls for two-state solution for Israel, Palestine

    The Golan and east Jerusalem were subsequently annexed but the moves were never recognised by the worldwide community. According to the report, hundreds of thousands of Palestinians have been imprisoned by Israel since 1967.

    Qatar FM to AP: No one has 'right to blockade my country'

    The move is a sign of support for the Gulf state in its dispute with its regional neighbors. Turkey has also stepped in to help Qatar, supplying the desert country with dairy products.

    "Dear Evan Hansen" Came Out On Top At The Tonys

    Last night, Bette Midler won a Tony for Best Leading Actress in a Musical for her role in the revival of Hello, Dolly! . Michael Aronov, who plays an Israeli diplomat in the play, also won a Tony for best featured actor. "I'm so privileged.
  • 'Dikshit's remarks against Army chief absolutely wrong'

    'Dikshit's remarks against Army chief absolutely wrong'

    Sandeep Dikshit triggered widespread outrage for his remarks, for which he later apologised. "It is his personal view". Dikshit is a former lawmaker from East Delhi and the son of former Delhi Chief Minister Sheila Dikshit.

    Pogba: Extreme Mourinho deserves to be called The Special One

    Against Chelsea , he changed our tactical formation just before the game. We had never trained it before but it worked out well [United won 2-0].

    Attorney General Jeff Sessions agrees to appear before Senate intelligence committee

    Sessions said he was "pleased to accept" the invitation to appear before members of the Senate Select Committee on Tuesday. In a letter sent to both the Republican and Democratic leaders of the Senate Intelligence Committee , Sen.
  • Polanski's victim pleads to end case: 'He owes me nothing'

    Polanski's victim pleads to end case: 'He owes me nothing'

    Polanski plied the girl with champagne and part of a sedative pill before raping her, according to grand jury transcripts. Judge Gordon, who praised Geimer for her courage and elegant words, said he would take the matter under consideration.
    Manchester United suffer transfer setback with Burnley's Michael Keane

    Manchester United suffer transfer setback with Burnley's Michael Keane

    That was down to the details of Keane's original move away from the club but the Red Devils have still opted against the move. However, The Sun claim the 24-year-old isn't convinced a move to Old Trafford would be the right step for his career.
    Half-staff flags, bells mark 1 year since Pulse massacre

    Half-staff flags, bells mark 1 year since Pulse massacre

    She says that people ask her what has changed in her life since the tragedy, and she says "everything". The eight Orlando-area high school graduates chosen are getting $4,900 toward their college studies.
  • Apple updates MacBook Air with a speed bump

    Apple updates MacBook Air with a speed bump

    Really, it's only mainstream consumers and creative types with more-limited needs (or means) who can safely buy an all-in-one now. With a bigger screen, it can conveniently make room for a full-size onscreen keyboard; yet, its weight remains unchanged at 477g.
    Pirates Of The Caribbean stays afloat while Baywatch makes small waves

    Pirates Of The Caribbean stays afloat while Baywatch makes small waves

    Pirates of the Caribbean: Dead Men Tell No Tales proved to be the biggest fish in this small box office seas. Check out the May 26-28 box office figures below.
    Services Will Mark 1 Year Since Pulse Nightclub Massacre

    Services Will Mark 1 Year Since Pulse Nightclub Massacre

    Among the attendees were four mothers whose children were gunned down by Omar Mateen in the pre-dawn hours of June 12, 2016. Monday marks one year since 49 people were killed and 53 more were wounded at Pulse nightclub .

OnePlus Settles OnePlus 2 Users Without Android Nougat Update , Confirms Company OnePlus Settles OnePlus 2 Users Without Android Nougat Update , Confirms Company The Chinese company officially confirmed for Android Authority that the OnePlus 2 will not get the Android 7.0 Nougat update . From the tweet, it is confirmed that the OnePlus 5 will feature a metal unibody build, most probably aluminum.

Gorsuch has unanimous first opinion for Supreme Court Gorsuch has unanimous first opinion for Supreme Court Gorsuch was the author of a unanimous decision in favor of a company involved in a debt collection dispute. The plaintiffs said that unscrupulous debt collectors could evade the law merely by buying the debt.

Roma, in fiamme 40 auto parcheggiate Per i due occupanti è scattato l'arresto con le accuse di resistenza a pubblico ufficiale e danneggiamento. La corsa è finita quando la loro macchina ne ha tamponata un'altra dei carabinieri.

Justices strike down citizenship law over gender differences Justices strike down citizenship law over gender differences Ginsburg was joined by Chief Justice John Roberts, and Justice Anthony Kennedy, Stephen Breyer, Sonia Sotomayor, and Elena Kagan. Under such scrutiny, she went on, the different treatment of mothers and fathers in the citizenship laws at issue can not stand.

Theresa May appoints new UK Cabinet as critics circle The Conservatives won 318 House of Commons seats in the election, eight short of an outright majority. Johnson, the tousled-haired former London mayor, dismissed the reports as "tripe".

Can still be next British PM: says Labour leader Corbyn Can still be next British PM: says Labour leader Corbyn This would give the Tories the numbers to pass a Queen's Speech on June 19, which will set out their legislative agenda. Some in Theresa May's own party called for her to step down as leader after the results came in.

E3 2017: The Evil Within 2 confermato ufficialmente E3 2017: The Evil Within 2 confermato ufficialmente Sopravvivi a sadiche creature decise a farti a pezzi e incontra personaggi che (forse) ti condurranno sulla via della redenzione. Shinji Mikami e il team Tango Gameworks sono lieti di annunciare The Evil Within 2 , l'evoluzione del survival Horror.

Latest Stocks: Nordic American Tanker Ltd (NAT) Declares Quarterly Dividend of $0.20 Wall Street is only getting more bullish on the stock, with 8 of analysts who cover GWB having a buy-equivalent rating. Finally, Legal & General Group Plc boosted its stake in Nordic American Tankers Limited by 5.6% in the first quarter.

French see no one to counter Macron, set to sweep parliament The final outcome will be decided in the second round of voting next Sunday, reported BBC . Few candidates reached the 50-percent mark needed for election at the first round.

Griftlands Announced: Don't Starve Dev Unveils New RPG Griftlands Announced: Don't Starve Dev Unveils New RPG That's not all though as it announced Griftlands , a role-playing game, that will be releasing in late 2017 and early 2018. There was a hint of combat that looks to be side-on team-based and turn-based.

Qatar begins shipping cargo through Oman to bypass Gulf rift The airline CEO said he did not expect Qatar to be treated in this way by a country "so dependent on its fight against terrorism". The Arab states blocked direct flights with Qatar and all except Bahrain barred Qatari flights from using their airspace.

Katy Perry opens up on livestream about suicidal thoughts Katy Perry opens up on livestream about suicidal thoughts Back in 2013, Groban told Details magazine that the two "might have skated on the line of dating". Katy Perry says John Mayer is the best lover she ever had, beating Orlando Bloom and Diplo .

'Dear Evan Hansen,' 'Oslo,' 'Hello, Dolly!,' win big at 2017 Tony Awards 'Dear Evan Hansen,' 'Oslo,' 'Hello, Dolly!,' win big at 2017 Tony Awards The Late Show host presented the award for Best Revival and quickly went on to talk about the "revival down in Washington, D.C". Michael Aronov , who plays an Israeli diplomat in the play, also won a Tony for best featured actor.

Bryan Robson urges Manchester United to make 'flair signings' United have long retained an interest in the 27-year-old, with both Sir Alex Ferguson and David Moyes trying to snap him up.

Google Pixel 2 Will Be A Real Challenge For Apple's iPhone 8 Google Pixel 2 Will Be A Real Challenge For Apple's iPhone 8 It is yet unclear if the render of the Google Pixel 2 is legitimate, as the image appears to be created by a fan. Google has also confirmed that the pixel phones will get the latest Android OS updates from Google directly.