Sandoz proposed biosimilar rituximab accepted for review by the FDA

  • Rituximab is indicated to treat blood cancers and immunological diseases such as rheumatoid arthritis1
  • Sandoz believes the comprehensive data package submitted to the FDA for review confirms that our biosimilar rituximab matches the reference medicine in terms of safety, efficacy and quality
  • The global leader in biosimilars, Sandoz has five biosimilars approved worldwide including biosimilar rituximab, which was approved in Europe* in June 20172

Holzkirchen, September 12, 2017 – …

/by

Lancet Haematology publishes data demonstrating Sandoz Rixathon® (biosimilar rituximab) matches efficacy and safety of reference biologic

  • Lancet Haematology publishes data from ASSIST-FL study of Sandoz Rixathon®, in patients with previously untreated advanced follicular lymphoma
  • ASSIST-FL, results of which were first announced in December 2017, achieved its primary endpoint1
  • Rixathon® received European Commission approval for use in all indications of the reference biologic in June 2017 2,3

Holzkirchen, August 29, 2017 – Lancet Haematology has published data from the ASSIST-FL trial demonstrating that the efficacy and safety of …

/by

Sandoz invests in major expansion of global headquarters in Holzkirchen, Germany

  • Expected investment will amount to approximately USD 50m
  • Decision to expand underlines confidence in growth potential of business
  • Modern campus facility will promote more collaborative ways of working

Holzkirchen, August 29, 2017 — Sandoz, the generic pharmaceuticals and biosimilars division of Novartis, announced today that it will further expand its global headquarters in Holzkirchen, near Munich. The expected investment will amount to approximately USD 50m.

Sandoz will begin construction of two …

/by

Sandoz expands partnership with World Child Cancer, to help children access treatment in four developing countries

  • Expanded partnership to help “even the odds” of survival for children with cancer in the Philippines, Myanmar, Mexico and Ghana
  • In developed countries, the survival rate for childhood cancer is 80%, while in developing countries it can be as low as 10%
  • Sandoz is committed to working with key stakeholders to pioneer novel ways of expanding access to healthcare

The digital press release with multimedia content can be accessed here: 

…

/by

Q2 results confirm full year guidance. Strong pipeline results underpin potential of several highly innovative products

  • Net sales in line with prior year (0% cc[1], -2% USD), as growth drivers offset Gleevec/Glivec Gx impact:
    • Cosentyx (USD 490 million, +90% cc) continues strong growth in all three indications
    • Entresto (USD 110 million) grew steadily driven by improved access and US sales force expansion
    • Excluding Gleevec/Glivec, Oncology grew 9% (cc), driven by Promacta, Tafinlar + Mekinist  and Jakavi
    • Sandoz declined 4% (cc) mainly impacted by increased US pricing pressure
    • Alcon grew 3% (cc) driven by Surgical (+3 …
/by

Sandoz receives approval in Europe for Erelzi® (biosimilar etanercept) to treat multiple inflammatory diseases

  • European Commission approves Sandoz Erelzi® to treat immunological diseases such as rheumatoid arthritis, psoriasis, and psoriatic arthritis
  • Approval of Erelzi provides more treatment options for healthcare professionals and patients and opens another chapter in the Sandoz immunology portfolio
  • Sandoz now has five biosimilars approved in Europe, including biosimilars of some of the world’s leading blockbuster biologics1

Holzkirchen, June 27, 2017 — Sandoz, a Novartis …

/by

Sandoz receives approval in Europe for Rixathon® (biosimilar rituximab) to treat blood cancers and immunological diseases

  • European Commission approves Sandoz Rixathon® to treat blood cancers and immunological diseases.
  • Approval expected to broaden patient access to biologics and enable budget-constrained healthcare systems to reallocate resources to other healthcare priorities.
  • Sandoz now has four biosimilars approved in Europe — more than any other company.1

Holzkirchen, June 19, 2017 — Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced today that the European …

/by

Sandoz receives approval in Europe for Rixathon® (biosimilar rituximab) to treat blood cancers and immunological diseases

  • European Commission approves Sandoz Rixathon® to treat blood cancers and immunological diseases.
  • Approval expected to broaden patient access to biologics and enable budget-constrained healthcare systems to reallocate resources to other healthcare priorities.
  • Sandoz now has four biosimilars approved in Europe — more than any other company.1

Holzkirchen, June 19, 2017 — Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced today that the European …

/by

FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus®

  • FDA accepts Sandoz ANDA for substitutable generic version of Advair Diskus®
  • Sandoz believes its combination product will offer asthma and COPD patients same safety and efficacy as reference medicine
  • Sandoz looks forward to working with FDA to drive access to this treatment option

Holzkirchen, June 15, 2017- Sandoz today announced that the US Food and Drug Administration (FDA) has accepted its Abbreviated New Drug Application for fluticasone propionate / salmeterol combination product, a substitutable …

/by

FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus®

  • FDA accepts Sandoz ANDA for substitutable generic version of Advair Diskus®
  • Sandoz believes its combination product will offer asthma and COPD patients same safety and efficacy as reference medicine
  • Sandoz looks forward to working with FDA to drive access to this treatment option

Holzkirchen, June 15, 2017- Sandoz today announced that the US Food and Drug Administration (FDA) has accepted its Abbreviated New Drug Application for fluticasone propionate / salmeterol combination product, a substitutable …

/by