Novartis delivered solid Q2 despite full quarter of US Gleevec generic impact; significant positive innovation news strengthens future growth prospects

  • Q2 net sales were flat (0% cc[1]) as Growth Products[2] offset Gleevec generic impact
    • Gilenya (USD 811 million, +17% cc) continued to grow double-digit mainly due to volume growth
    • Cosentyx (USD 260 million) grew strongly driven by its three approved indications
  • Core[1] operating income declined (-4% cc) due to generic erosion and growth investments
    • Core M&S expenses up 0.8 percentage points (cc) to 24.6% of sales, mainly driven by Cosentyx, Entresto and Alcon …
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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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