US Supreme Court rules in favor of Sandoz in biosimilars case, enabling earlier access to potentially life-saving medicines

  • US Supreme Court rules that six months’ notice of commercial marketing can be given prior to FDA approval in Sandoz vs. Amgen
  • Justices also provided much needed clarity on the patent litigation process, often referred to as the ‘patent dance’
  • As the first company to gain approval for and launch a biosimilar under the BPCIA’s new regulatory pathway, Sandoz continues to pioneer the path forward for these high-quality, cost-effective medicines in the US

Holzkirchen, 13 June 2017 – Sandoz, a Novartis division, today announced that the Supreme …

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US Supreme Court rules in favor of Sandoz in biosimilars case, enabling earlier access to potentially life-saving medicines

  • US Supreme Court rules that six months’ notice of commercial marketing can be given prior to FDA approval in Sandoz vs. Amgen
  • Justices also provided much needed clarity on the patent litigation process, often referred to as the ‘patent dance’
  • As the first company to gain approval for and launch a biosimilar under the BPCIA’s new regulatory pathway, Sandoz continues to pioneer the path forward for these high-quality, cost-effective medicines in the US

Holzkirchen, 13 June 2017 – Sandoz, a Novartis division, today announced that the Supreme …

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US Supreme Court clears way to early access to biosimilars

“Biosimilars offer significant value to patients, providers and payers, increasing the number of treatment options available to patients across many disease areas at a reduced cost to the healthcare system.  The Justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments. We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward,” said Carol Lynch, Global Head of Biopharmaceuticals, Sandoz. “As the global leader in biosimilars, it is our responsibility to help …

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US Supreme Court clears way to early access to biosimilars

“Biosimilars offer significant value to patients, providers and payers, increasing the number of treatment options available to patients across many disease areas at a reduced cost to the healthcare system.  The Justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments. We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward,” said Carol Lynch, Global Head of Biopharmaceuticals, Sandoz. “As the global leader in biosimilars, it is our responsibility to help …

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At the Meet Novartis Management investor event, Novartis highlights focus on innovation and productivity; expects the next growth phase to begin in 2018

  • Building depth across key therapeutic areas with 12 potential blockbusters in late stage development and 40 potential filings in US and EU between 2017-2020
  • Focused and taking steps to become stronger and more integrated through centralized manufacturing, development and business services
  • Poised for next growth phase, anticipated to begin in 2018

Boston, May 31, 2017 – Today Novartis holds its fourth annual Meet Novartis Management event at its research headquarters in Cambridge, MA, giving …

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At the Meet Novartis Management investor event, Novartis highlights focus on innovation and productivity; expects the next growth phase to begin in 2018

  • Building depth across key therapeutic areas with 12 potential blockbusters in late stage development and 40 potential filings in US and EU between 2017-2020
  • Focused and taking steps to become stronger and more integrated through centralized manufacturing, development and business services
  • Poised for next growth phase, anticipated to begin in 2018

Boston, May 31, 2017 – Today Novartis holds its fourth annual Meet Novartis Management event at its research headquarters in Cambridge, MA, giving …

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Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the European Medicines Agency

  • Sandoz is seeking approval for their proposed biosimilars adalimumab and infliximab for use in all indications of their respective reference medicines, Humira®* and Remicade®†
  • Comprehensive data packages demonstrate each biosimilar matches its respective reference medicine in terms of quality, efficacy and safety
  • These regulatory submissions follow soon after two positive CHMP opinions** for Sandoz biosimilars etanercept and rituximab further reinforcing Sandoz immunology pipeline and the broader Novartis immunology portfolio

    • …

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Novartis delivered sales growth across all divisions (cc1) as growth drivers, including Cosentyx and Entresto, more than offset generic erosion; innovation momentum continued

  • Net sales grew 2% (cc, -1% USD), as growth drivers more than offset Gleevec/Glivec impact
    • Cosentyx (USD 410 million, +136% cc) showing strong growth in all three indications
    • Entresto (USD 84 million) steadily growing with better access in US and EU
    • Gilenya (USD 722 million, +5% cc) grew mainly driven by volume
    • Excluding Gleevec/Glivec, Oncology grew +7% (cc) driven mainly by Promacta/Revolade, Jakavi, Tafinlar + Mekinist and Tasigna
  • Core[1] operating income down 5% (cc) due to generic erosion and increased investments, mainly …
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Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe*

  • Sandoz receives positive CHMP opinions for biosimilars rituximab and etanercept to treat immunological diseases.  Biosimilar rituximab also recommended to treat blood cancers
  • Comprehensive data packages, confirming Sandoz biosimilars rituximab and etanercept match their respective reference medicines, were the basis for CHMP decisions
  • Subject to EC** approval, Sandoz market leadership position extended as the only company to have five approved biosimilars in Europe1

Holzkirchen, April 21, 2017 – Sandoz …

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Major Novartis investment in Slovenia reinforces commitment to largest Sandoz product and business

  • Total investment of EUR 105 million in Prevalje site reinforces commitment to largest Sandoz business, Anti-Infectives, and single largest global product, broad-spectrum antibiotic amoxicillin-clavulanic acid.
  • The investment will bring 150 new jobs, more than doubling the number of employees at Prevalje over six years.
  • The project, scheduled for completion in 2019, will be the largest Novartis investment in Slovenia to date.

Prevalje, April 11, 2017 – A foundation stone for the new production plant for a broad- …

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