Sandoz advances its biosimilars program with EMA acceptance of regulatory submission for biosimilar pegfilgrastim

  • Sandoz’ late-stage biosimilar pipeline gains momentum with sustained investment – five of 10 planned regulatory filings achieved

  • Sandoz believes that the totality of evidence in its submission, including three pivotal clinical studies, demonstrates that the proposed biosimilar is highly similar to the reference product.

  • Sandoz is the European market leader in both the daily G-CSF class and for biosimilar filgrastim.

Holzkirchen, 11 February, 2016 – Sandoz, a Novartis company and the global leader in biosimilars, …

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Sandoz’s Carol Lynch elected as chair of EGA’s European biosimilars group

Holzkirchen, February 10, 2016 – Today, Sandoz announced that the European Generic Medicines Association (EGA) has elected Carol Lynch, Global Head Biopharmaceuticals & Oncology Injectables, Sandoz as Chair of its European Biosimilars Group (EBG).

In this role Lynch, along with fellow EBG members, will support the expansion of patient access to high-quality biosimilar medicines, while ensuring the sustainability of the industry. Lynch believes that the industry’s areas of focus, under her tenure, for the next two years should be: 

  • Increasing …
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Sandoz’s Carol Lynch elected as chair of EGA’s European biosimilars group

Holzkirchen, February 10, 2016 – Today, Sandoz announced that the European Generic Medicines Association (EGA) has elected Carol Lynch, Global Head Biopharmaceuticals & Oncology Injectables, Sandoz as Chair of its European Biosimilars Group (EBG).

In this role Lynch, along with fellow EBG members, will support the expansion of patient access to high-quality biosimilar medicines, while ensuring the sustainability of the industry. Lynch believes that the industry’s areas of focus, under her tenure, for the next two years should be: 

  • Increasing …
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Novartis delivered strong sales growth and core margin expansion in 2015; announces plans to accelerate growth at Alcon, streamline Group operations

Basel, January 27, 2016 – Novartis delivered strong sales growth and core margin expansion (cc[1]) in 2015; announces plans to accelerate growth at Alcon, streamline Group operations

  • Strong growth (cc) in full year sales, core operating income and core EPS[2]
    • Net sales up 5% (cc) and core operating income up 10% (cc)
    • Core operating income margin up 1.3 percentage points (cc)
    • Operating income (-2% cc) down mainly due to amortization of the new oncology assets
    • Net income (-18% cc) impacted by exceptional gains in …
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Novartis delivered strong sales growth and core margin expansion in 2015; announces plans to accelerate growth at Alcon, streamline Group operations

Basel, January 27, 2016 – Novartis delivered strong sales growth and core margin expansion (cc[1]) in 2015; announces plans to accelerate growth at Alcon, streamline Group operations

  • Strong growth (cc) in full year sales, core operating income and core EPS[2]
    • Net sales up 5% (cc) and core operating income up 10% (cc)
    • Core operating income margin up 1.3 percentage points (cc)
    • Operating income (-2% cc) down mainly due to amortization of the new oncology assets
    • Net income (-18% cc) impacted by exceptional gains in …
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Sandoz licenses its biosimilar rituximab to Kyowa Hakko Kirin in Japan

Holzkirchen, 25 January, 2016 – Sandoz, a Novartis company and the global leader in biosimilars, announced today that it has entered into an exclusive license agreement with Kyowa Hakko Kirin Co., Ltd for the distribution and promotion of its biosimilar rituximab – a monoclonal antibody, in Japan.

Under the terms of the agreement, Sandoz will file for marketing authorization of biosimilar rituximab and its manufacture if approved. Kyowa Hakko Kirin will be responsible for all sales, marketing and promotion activities in Japan.

Kyowa Hakko Kirin will pay Sandoz …

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Novartis moves to address superbug threat

Rex Clements, Head of Business Unit Anti-Infectives & API comments on the antimicrobial resistance declaration:

Listen to the audio (1:23 min).mp3

…

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Sandoz advances its biosimilars program with European Medicines Agency (EMA) acceptance of regulatory submission for biosimilar etanercept

  • Sandoz is seeking approval for all indications included in the reference product’s label which includes chronic inflammatory conditions like rheumatoid arthritis and psoriasis.
  • Sandoz believes that the totality of evidence in its submission, including two pivotal clinical studies, will demonstrate that the biosimilar etanercept is highly similar to the reference product.
  • EMA acceptance follows recent FDA regulatory submission acceptance and is the third of ten regulatory filings planned over a three year period (2015-2017).

Holzkirchen, 8 December, …

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Phase III data shows Sandoz’ proposed biosimilar pegfilgrastim has similar safety and efficacy as the reference product

  • PROTECT 2 study compared safety and efficacy of the proposed biosimilar pegfilgrastim with the reference product for the prevention of neutropenia in patients with breast cancer.
  • The study met its primary endpoints demonstrating equivalence and non-inferiority to the reference product.
  • Data presented at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition.

Holzkirchen, 7 December 2015 – Sandoz, a Novartis company and global leader in biosimilars, today announced results from the PROTECT 2 study which compared the …

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Sandoz comments on the FDA’s proposed rule for Designation of Official Names and Proper Names for Certain Biological Products

The Novartis Group of companies, recently provided comments on the U.S. Food and Drug Administration (FDA) Proposed Rule entitled “Designation of Official Names and Proper Names for Certain Biological Products”.

As the first company to market a biosimilar in the US, Sandoz, a Novartis company, shares the FDA’s commitment to patient safety and to ensuring accurate perceptions of the safety and effectiveness of biological products.

Sandoz believes biosimilars and interchangeable biologics should share the same non-proprietary name as their respective reference products and that …

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