Sandoz receives positive CHMP opinion for proposed biosimilar infliximab

  • Sandoz is seeking approval of biosimilar infliximab for use in all indications of its reference medicine across gastroenterology, rheumatology and dermatology
  • Positive opinion is based on comprehensive clinical and non-clinical data that is expected to confirm that Sandoz biosimilar infliximab matches the reference medicine
  • This recommendation marks the third CHMP positive opinion granted for a Sandoz biosimilar in 12 months following Erelzi® and Rixathon®; Sandoz is on track to launch several biosimilars of major oncology …
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Sandoz announces US FDA approval and launch of Glatopa® 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis

  • Glatopa® 40 mg/mL is a fully substitutable, AP-rated generic version of Copaxone®* (glatiramer acetate injection) 40 mg/mL
  • Glatopa 40 mg/mL, along with Glatopa® 20 mg/mL, which was launched in the US in June 2015, will offer patients a complete range of dosing options
  • A full range of patient support services for Glatopa® is available through GlatopaCare®

Holzkirchen, February 13, 2018 – Sandoz, a Novartis division, today announced the US FDA approval …

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Sandoz certified as Top Employer Europe 2018

  • Sandoz has been officially certified by the Top Employers Institute for its exceptional employee offerings in Europe and Russia
  • The annual, international research undertaken by the Top Employers Institute recognizes leading employers around the world
  • This exclusive certification underlines Sandoz´ commitment to attract and retain the best people from the industry

Holzkirchen, February 1, 2018 – Sandoz, a Novartis division, is proud to announce that it has officially been certified “TOP Employer Europe 2018” for …

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Novartis delivered good operational performance and landmark innovation in 2017, entering our next growth phase

  • Full year sales grew 2% (cc, +1% USD) as strong performance of our growth drivers, including Cosentyx and Entresto, more than offset Gleevec/Glivec generic erosion:
    • Cosentyx grew to USD 2.1 billion in 2017, USD 615 million in Q4
    • Entresto grew to USD 507 million in 2017, USD 185 million in Q4
    • Oncology excluding Gleevec/Glivec grew 10% (cc), with 13% (cc) growth in Q4
  • Full year 2017 core[1] operating income was broadly in line with prior year (0% cc …
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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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