Sandoz announces exclusive global collaboration with Biocon on next-generation biosimilars

  • Collaboration aims to help patients worldwide gain access to a range of high-quality, affordable immunology and oncology biologics
  • Partnership will be an important part of Sandoz and Biocon strategy to address the next wave of biosimilar opportunities globally
  • Collaboration will leverage combined strengths of development, manufacturing and commercialization of biosimilars
  • Partnership provides foundation for expansion of portfolio 

Holzkirchen, 18 January 2018 – Sandoz, a Novartis …

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Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA

  • Adalimumab is an anti-TNF medicine used to treat a range of immunological diseases[1]
  • The comprehensive data package provided is expected to demonstrate that Sandoz proposed biosimilar adalimumab matches the reference biologic medicine in terms of safety, efficacy and quality[2]-[4]

Holzkirchen, January 16, 2018 – Sandoz, a Novartis division and the global leader in biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA), submitted under the 351 (k …

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Sandoz announces new Phase I data showing proposed biosimilar pegfilgrastim matches reference medicine

  • Phase I study demonstrates matching pharmacokinetic (PK), pharmacodynamic (PD), safety and immunogenicity profiles of Sandoz biosimilar pegfilgrastim and reference medicine
  • Pegfilgrastim is a long-acting version of the oncology supportive care medicine filgrastim

Holzkirchen, 08 December 2017– Sandoz, a division of Novartis  and the global leader in biosimilars, today announced data demonstrating the pharmacokinetics (PK), pharmacodynamics (PD), safety and immunogenicity of proposed biosimilar pegfilgrastim as compared to the …

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Sandoz Scientific Standalone Event in Russia “Combat Infections to Save Lives”

  • Sandoz Scientific Standalone Event “Combat Infections to Save Lives” aims at increasing access to information in the field of antibiotic therapies in Central & Eastern Europe and Middle East & Africa (CEEMEA)
  • First event in the field of anti-infectives is utilizing digital platforms to reach healthcare professionals with state-of-art information shared by internationally recognized and trusted experts.

Holzkirchen, November 15, 2017 – Sandoz is holding today a Scientific Standalone Event “Combat …

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New data reinforces clinical basis for switching to Sandoz biosimilar medicines

  • Sandoz strengthens position as global leader in biosimilars with new immunology data from four clinical studies for proposed biosimilars adalimumab and rituximab
  • Efficacy and safety of biosimilar adalimumab and safety of biosimilar rituximab match reference medicines in multiple-switching and retreatment study respectively 
  • Sandoz biosimilar adalimumab is under EMA review, while EC-approved Sandoz biosimilar rituximab is under review by the FDA

Holzkirchen, November 14, 2017– Sandoz, a Novartis division and the global leader in …

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Sandoz proposed biosimilar pegfilgrastim accepted by EMA for regulatory review

  • Comprehensive data package demonstrates that Sandoz biosimilar pegfilgrastim matches the reference biologic in terms of safety, efficacy and quality
  • Pegfilgrastim is a long-acting version of oncology medicine filgrastim — Sandoz is the European market leader for filgrastim  
  • Sandoz is the global leader in biosimilars, with five biosimilars marketed worldwide and a leading global pipeline, including three biosimilars currently under EMA review

Holzkirchen, October 27, 2017 – Sandoz, a Novartis Division, and the global leader in biosimilars …

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Novartis delivered growth on top and bottom line in all divisions in Q3

  • Net sales grew 2% (cc[1], +2% USD), with growth in all divisions:
    • Cosentyx (USD 556 million, +83% cc) showed strong growth across all indications
    • Entresto (USD 128 million, +138% cc) grew driven by improved access and US sales force expansion
    • Excluding Gleevec/Glivec, Oncology grew 11% (cc)
    • Alcon was up 7%[2] (cc) with strong growth in Surgical and continued growth in Vision Care
    • Sandoz grew 1% (cc) driven by growth outside the US, fully offsetting US price pressure

      • …

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Novartis delivered growth on top and bottom line in all divisions in Q3

  • Net sales grew 2% (cc[1], +2% USD), with growth in all divisions:
    • Cosentyx (USD 556 million, +83% cc) showed strong growth across all indications
    • Entresto (USD 128 million, +138% cc) grew driven by improved access and US sales force expansion
    • Excluding Gleevec/Glivec, Oncology grew 11% (cc)
    • Alcon was up 7%[2] (cc) with strong growth in Surgical and continued growth in Vision Care
    • Sandoz grew 1% (cc) driven by growth outside the US, fully offsetting US price pressure

      • …

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Sandoz proposed biosimilar adalimumab matches reference biologic in terms of efficacy and safety in long-term study

  • 51-week clinical study confirms that  Sandoz proposed biosimilar adalimumab matches reference medicine Humira®* safety and efficacy profile1
  • Sandoz proposed biosimilar adalimumab is currently under review by the European Medicines Agency for the treatment of several immunological diseases
  • Sandoz expects that approval of biosimilar adalimumab would further improve access to treatment for people living with immunological diseases

 Holzkirchen, September 14, 2017 – Sandoz, a Novartis …

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Sandoz proposed biosimilar rituximab accepted for review by the FDA

  • Rituximab is indicated to treat blood cancers and immunological diseases such as rheumatoid arthritis1
  • Sandoz believes the comprehensive data package submitted to the FDA for review confirms that our biosimilar rituximab matches the reference medicine in terms of safety, efficacy and quality
  • The global leader in biosimilars, Sandoz has five biosimilars approved worldwide including biosimilar rituximab, which was approved in Europe* in June 20172

Holzkirchen, September 12, 2017 – …

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