FDA accepts Sandoz application biosimilar filgrastim

  • Sandoz is the first company to announce it has filed for approval of a biologic under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA)
  • FDA’s acceptance of Sandoz’s filing is an important first step in increasing US patient access to affordable, high-quality biologics
  • Sandoz is a global leader in biosimilars with over 50% share of the global biosimilars market1

Holzkirchen, July 24, 2014 – Sandoz, a Novartis Group company, announced today that the US Food and Drug Administration (FDA) has …

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Sandoz obtains rights in US to commercialize Kerydintm (Tavaborole) topical solution, 5% from Anacor Pharmaceuticals, INC.

Princeton, New Jersey, July 21, 2014 – Sandoz today announced an agreement with Anacor Pharmaceuticals, Inc. to obtain exclusive rights to commercialize Anacor’s drug KERYDINTM (tavaborole) topical solution, 5% in the US, through its branded dermatology business, PharmaDerm.

Two weeks ago Anacor announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application for KERYDINTM, the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes, a fungal …

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Sandoz launches authorized generic version of Tobi®

Princeton, New Jersey, July 14, 2014 – Sandoz today announced the US market introduction of tobramycin inhalation solution, USP, an authorized generic version of TOBI®, currently marketed by Novartis Pharmaceuticals Corporation1.

Tobramycin inhalation solution, USP is indicated for the management of cystic fibrosis patients whose lungs contain bacteria called P. aeruginosa.

Cystic fibrosis is a life-threatening genetic disease that primarily affects the lungs and digestive system. An estimated 30,000 children and adults in the United States (70,000 …

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Novartis maintained strong innovation momentum in second quarter, while reconfirming full year outlook

Basel, July 17, 2014 – Commenting on the results, Joseph Jimenez, CEO of Novartis, said: “Novartis delivered solid financial performance with core margin expansion in the second quarter and first half. Pharmaceuticals, in particular, showed improved productivity, driving core operating leverage for the Group. We also made significant progress on innovation across the portfolio, reaching milestones such as FDA approval for Zykadia in ALK+ non-small cell lung cancer, FDA Fast Track designation and rolling submission for LCZ696 in chronic heart failure, CHMP recommendation …

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Sandoz’s Joerg Windisch reelected as chair of Ega’s European biosimilars group

Today, Sandoz announced that the European Generic medicines Agency (EGA) has reelected Dr. Joerg Windisch, Chief Science Officer at Sandoz, as chair of its European Biosimilars Group (EBG).

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Sandoz launches authorized generic version of Diovan® in the US

Princeton, New Jersey, July 8, 2014 – Sandoz today announced the US introduction of an authorized generic version of Diovan® (valsartan) tablets for the treatment of high blood pressure (HBP).

​This launch follows the Sandoz US introduction of an authorized generic version of Diovan HCT® (valsartan and hydrochlorothiazide) in 2012. Both Diovan and Diovan HCT are marketed in the US by Novartis Pharmaceuticals Corporation (NPC) and are indicated for the treatment of HBP, a condition that affects approximately one in three US adults.1,2

“We are pleased to offer …

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Sandoz brings together key French stakeholders to discuss biosimilars

Sandoz, the global leader in biosimilars, recently hosted an event in Paris for key stakeholders to discuss strategic issues impacting biosimilars and help them better understand their vital role in the success of these important therapies in France.

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