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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Sandoz continues to advance its biosimilars program: Regulatory submission for Sandoz’ proposed biosimilar pegfilgrastim accepted by the FDA

  • Sandoz demonstrates commitment to oncology by seeking approval for its proposed biosimilar pegfilgrastim.
  • Sandoz believes that the totality of evidence in its submission, including three pivotal clinical studies, will demonstrate that the proposed biosimilar is highly similar to the reference product.
  • Proposed biosimilar pegfilgrastim filing is the second of ten regulatory filings planned over the next three years.

Holzkirchen, November 18, 2015 – Sandoz, a Novartis company and the global leader in biosimilars, announced today that the US …

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Generic medicines saved US healthcare system more than USD 250 billion in 2014 alone

Generic medicines saved the US healthcare system a record USD 254 billion in 2014, according to a new report compiled by the IMS Institute for Healthcare Informatics on behalf of the US Generic Pharmaceutical Association (GPhA).

Chip Davis, President and CEO of the GPhA, said: “The facts are irrefutable, generic drugs drive enormous health care savings.

“This new report reinforces that generic drugs are a critical part of any solution to rising costs for patients, payors and the entire healthcare system. Safe, effective and more affordable generic medicines mean increased …

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Novartis delivered strong core margin expansion (cc) and continued to strengthen the pipeline in Q3; on track for full – year guidance

Basel, October 27, 2015 – Commenting on the results, Joseph Jimenez, CEO of Novartis, said: “Novartis continued to make strong progress on innovation and key launches in the third quarter. The Pharmaceuticals and Sandoz Divisions continue to perform exceptionally well, offsetting softness in the Alcon Division. Entresto was approved and launched in the US, and Tafinlar + Mekinist was approved in the EU for BRAF-mutant melanoma. We confirm our full – year guidance.”

  • Solid growth (cc[1]) in Q3 sales, core operating income, core EPS for continuing …
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Sandoz introduces authorized generic version of LESCOL® XL in the US

Princeton, New Jersey, October 16, 2015 – Sandoz today announced the US introduction of fluvastatin sodium extended-release tablets, USP, an authorized generic version (AGx) of LESCOL® XL, which is marketed by Novartis Pharmaceuticals Corporation. This is another great example of cross-divisional collaboration in the context of the ongoing Novartis Group Rx-Gx program.

Fluvastatin sodium extended-release tablets, USP are indicated as an adjunctive therapy with changes to diet to lower cholesterol, slow the progression of heart disease and reduce the risk of needing …

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Kenya is first country to launch ‘Novartis Access’, expanding affordable treatment options against chronic diseases

  • Novartis Access is a first-of-its-kind portfolio of products aimed at increasing access to medicines against cardiovascular diseases, diabetes, respiratory illnesses and breast cancer in low- and low-middle-income countries
  • Program supports Kenyan government on noncommunicable disease (NCD) prevention and control – by 2030, NCDs are expected to cause more than 60% of deaths in the country1
  • Agreements signed with Kenyan government and NGOs include programs to distribute medicines, raise disease awareness and strengthen healthcare system capabilities in key …
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