Sandoz biosimilar etanercept recommended by FDA advisory committee for approval to treat multiple inflammatory diseases

  • Committee votes unanimously in favor of the Sandoz proposed biosimilar etanercept for all approved indications of the reference product
  • Committee’s recommendation based on totality of evidence from global development program showing biosimilar etanercept is highly similar to Enbrel®*

Holzkirchen, 13 July, 2016. Sandoz, a Novartis division and leader in biosimilars, announced today that the US Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of its proposed biosimilar etanercept. The committee voted unanimously ( …

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New data shows Sandoz biosimilar etanercept candidate has equivalent efficacy to originator product

  • The EGALITY study met its primary endpoint demonstrating equivalent efficacy of Sandoz biosimilar etanercept candidate to the originator product at week 12
  • As a first-of-its kind, the confirmatory clinical safety and efficacy study compares originator etanercept to a biosimilar candidate in psoriasis
  • Sandoz biosimilar etanercept has been accepted for review by the EMA* and FDA**

Holzkirchen, July 7, 2016 – Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, today announced results from the EGALITY trial in which …

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Sandoz announces plans for five major global biosimilar launches by 2020

  • Progress on biosimilar pipeline paves way for five planned launches by 2020
  • Sandoz now plans a total of 11 biosimilar filings by end 2017 (EU and US) and has already delivered on six
  • Investments of more than USD 1 billion in state of-the-art biomanufacturing facilities, backed by industry-leading capabilities as part of Novartis, positions Sandoz to deliver biosimilars at unprecedented scale

Holzkirchen, June 20, 2016 – Sandoz, a Novartis Division and the global leader in biosimilars, plans to launch five biosimilars of major oncology and …

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New data demonstrates Sandoz’ etanercept and rituximab biosimilar candidates bioequivalent to originator products

  • Sandoz’ biosimilar etanercept candidate shows pharmacokinetic (PK) bioequivalence with no clinically meaningful differences in safety, tolerability and immunogenicity to the originator.1

  • Sandoz’ biosimilar rituximab candidate shows PK bioequivalence and similar pharmacodynamics (PD), safety, efficacy and immunogenicity.2

  • Biosimilar etanercept candidate is under regulatory review by EMA* and FDA** and biosimilar rituximab candidate is undergoing EMA review.

Holzkirchen, June 9, 2016 – Sandoz, a …

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Sandoz’ biosimilar rituximab regulatory submission accepted by European Medicines Agency

  • Sandoz advances biosimilar portfolio with sixth major biosimilar file acceptance in less than one year

  • Sandoz is seeking approval for all indications included in the reference product’s label

  • Sandoz’ submission includes data from multiple clinical trials with over 800 patients

Holzkirchen, 24 May, 2016 – Sandoz, a Novartis division and the global leader in biosimilars, announced today that the European Medicines Agency has accepted their Marketing Authorization Application for a biosimilar to Roche’s EU-licensed …

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Ecuador earthquake recovery: Sandoz announces financial support and product donation

Holzkirchen, May 23, 2016 – In the wake of the earthquake that devastated northwest Ecuador in April, Sandoz, a Novartis division, today announced that it will support the recovery effort with financial aid and a product donation.

Hundreds of people lost their lives in the earthquake, which injured thousands more, devastated communities and left approximately 25,000 people living in shelters.

Employees locally have already been actively involved in a variety of relief operations, including preparing emergency kits of food and hygiene items for delivery to the …

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Sandoz’s Carol Lynch, Global Head Biopharmaceuticals is recognized in a Top 100 list, as the eighth most influential individual in medicine making

Holzkirchen, 29 April, 2016 – Sandoz’s Carol Lynch, Global Head Biopharmaceuticals, has been named as one of the most influential people involved in bringing medicines to patients by Medicine Maker – a leading international publication focused on drug development. Lynch was recognized as the eighth most influential in a Top 100 list that includes some of the most prominent and inspirational individuals involved in medicine making today.

Nominations were proposed by the publication’s readers and ranked by an expert judging panel. Individuals in the Top 100 …

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Sandoz’s Carol Lynch, Global Head Biopharmaceuticals is recognized in a Top 100 list, as the eighth most influential individual in medicine making

Holzkirchen, 29 April, 2016 – Sandoz’s Carol Lynch, Global Head Biopharmaceuticals, has been named as one of the most influential people involved in bringing medicines to patients by Medicine Maker – a leading international publication focused on drug development. Lynch was recognized as the eighth most influential in a Top 100 list that includes some of the most prominent and inspirational individuals involved in medicine making today.

Nominations were proposed by the publication’s readers and ranked by an expert judging panel. Individuals in the Top 100 …

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Novartis delivered solid Q1 despite Gleevec loss of exclusivity; investing behind new launches for long-term growth

  • Net sales up 1% (cc[1]), as Growth Products offset Gleevec impact

    • Growth Products[2] grew 24% (USD) to USD 3.9 billion, or 34% of Group net sales

    • Cosentyx (USD 176 million) continues to grow strongly, benefitting from long-term efficacy data for psoriasis and new launches in AS and PsA[3]

    • Entresto (USD 17 million) launch continues to accelerate in EU, field force ramping up in US

  • Core[1] operating income declines (-5% cc), driven by generic …
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Novartis delivered solid Q1 despite Gleevec loss of exclusivity; investing behind new launches for long-term growth

  • Net sales up 1% (cc[1]), as Growth Products offset Gleevec impact

    • Growth Products[2] grew 24% (USD) to USD 3.9 billion, or 34% of Group net sales

    • Cosentyx (USD 176 million) continues to grow strongly, benefitting from long-term efficacy data for psoriasis and new launches in AS and PsA[3]

    • Entresto (USD 17 million) launch continues to accelerate in EU, field force ramping up in US

  • Core[1] operating income declines (-5% cc), driven by generic …
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