Sandoz receives approval in Europe for Rixathon® (biosimilar rituximab) to treat blood cancers and immunological diseases

  • European Commission approves Sandoz Rixathon® to treat blood cancers and immunological diseases.
  • Approval expected to broaden patient access to biologics and enable budget-constrained healthcare systems to reallocate resources to other healthcare priorities.
  • Sandoz now has four biosimilars approved in Europe — more than any other company.1

Holzkirchen, June 19, 2017 — Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced today that the European …

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FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus®

  • FDA accepts Sandoz ANDA for substitutable generic version of Advair Diskus®
  • Sandoz believes its combination product will offer asthma and COPD patients same safety and efficacy as reference medicine
  • Sandoz looks forward to working with FDA to drive access to this treatment option

Holzkirchen, June 15, 2017- Sandoz today announced that the US Food and Drug Administration (FDA) has accepted its Abbreviated New Drug Application for fluticasone propionate / salmeterol combination product, a substitutable …

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FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus®

  • FDA accepts Sandoz ANDA for substitutable generic version of Advair Diskus®
  • Sandoz believes its combination product will offer asthma and COPD patients same safety and efficacy as reference medicine
  • Sandoz looks forward to working with FDA to drive access to this treatment option

Holzkirchen, June 15, 2017- Sandoz today announced that the US Food and Drug Administration (FDA) has accepted its Abbreviated New Drug Application for fluticasone propionate / salmeterol combination product, a substitutable …

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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 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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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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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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