FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept

  • Etanercept is an anti-TNF medicine used to treat a range of immunological diseases including rheumatoid arthritis and psoriasis.
  • Sandoz is seeking approval for all indications included in the reference product’s label.
  • Sandoz believes that the totality of evidence in its submission, including two pivotal clinical studies, will demonstrate that the proposed biosimilar is essentially the same as the reference product.

Holzkirchen, October 2, 2015 – Sandoz, a Novartis company and the global leader in biosimilars, announced today that the US …

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World Heart Day 2015: Joining forces to fight the #1 cause of death worldwide

September 29, 2015 – An estimated 17.3 million people die of cardiovascular diseases every year. That makes it the number one cause of death in the world today, with 80% of those deaths occurring in low- and middle-income countries. Ischemic heart disease (e.g. heart attacks) is responsible for 7.3 million of total CVD deaths and cerebrovascular disease (e.g. strokes) for a further 6.2 million.

The big causes of cardiovascular disease

The …

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Novartis launches ‘Novartis Access’, a portfolio of affordable medicines to treat chronic diseases in lower-income countries

  • First-of-its-kind portfolio approach in healthcare industry, aiming to increase availability and affordability of 15 medicines against cardiovascular diseases, diabetes, respiratory illnesses and breast cancer
  • Novartis portfolio to be offered to governments and non-governmental organizations in low- and low-middle-income countries for USD 1 per treatment, per month
  • Some 28 million people die from chronic diseases in low- and middle-income countries each year, representing 75% of such deaths globally1

New York, September 24, 2015 …

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Sandoz Inaugurates BioInject – a new state-of-the-art biopharmaceutical manufacturing facility in Schaftenau, Austria

  • Sandoz is investing over 150 million euro and creating 100 new highly qualified jobs
  • The new BioInject facility will support Sandoz’s fast growing biosimilars business as well as other Novartis biologics
  • State-of-the-art technology will strengthen Sandoz and Novartis in-house capabilities in drug product manufacturing

Schaftenau, September 17 2015 – Sandoz, the generics and biosimilars business of Novartis, today officially opened its new cutting-edge biomanufacturing facility called BioInject, at Schaftenau in the Tyrolean Alps in Austria …

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Sandoz launches Zarxio™ (filgrastim-sndz), the first biosimilar in the United States

Holzkirchen, September 3, 2015 – Sandoz, a Novartis company, announced today that ZarxioTM (filgrastim-sndz) is now available in the United States. Zarxio is the first biosimilar approved by the US Food and Drug Administration (FDA) and the first to launch in the US.

“As the pioneer and global leader in biosimilars, Sandoz has maintained a commitment to bringing high-quality biosimilar medicines to patients and healthcare professionals around the world,” said Richard Francis, Global Head, Sandoz. “With the launch of Zarxio, we look forward to increasing …

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Sandoz launches generic version of Pulmicort Respules®

Princeton, New Jersey, July 28, 2015– Sandoz today announced the US market introduction of its budesonide inhalation suspension, a generic version of Pulmicort Respules® (budesonide) inhalation suspension 1 mg strength by AstraZeneca LP.

Sandoz’s budesonide inhalation suspension product is indicated for maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Budesonide inhalation suspension is not indicated for the relief of acute bronchospasm.

“Asthma is unfortunately becoming increasingly prevalent while few …

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Sandoz launches Breathe Africa program to improve asthma diagnosis, treatment and patient outcomes in Zambia

  • Non-communicable diseases like asthma are rising rapidly in sub-Saharan Africa where healthcare systems are ill-prepared to cope1 – Zambia is ranked #1 in the world for mortality due to asthma2
  • Increasing the medical expertise of local healthcare professionals is a quick and sustainable way to improve patient health outcomes3,4
  • Sandoz is calling on European doctors with an interest in asthma to volunteer for Breathe Africa

Holzkirchen, July 24, 2015 – Sandoz today announced the launch of Breathe Africa, a respiratory …

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Court ruling paves the way for launch of Sandoz’s Zarxio as first US biosimilar

Holzkirchen, Germany, July 22, 2015 – The US Court of Appeals for the Federal Circuit issued a ruling on July 21 that paves the way for Sandoz to launch Zarxio (filgrastim) after September 2, as the first US biosimilar.

The court, which ruled following an appeal hearing on June 3, found that provision of the biosimilar application to the originator company within 20 days of filing – the so-called “patent dance” component of the US biosimilar approval pathway, or BPCIA — is optional.

However, it also ruled that the required notice of commercial marketing can …

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Novartis delivered solid performance in the second quarter, with strong innovation and progress on new launches

Basel, July 21, 2015 – Commenting on the results, Joseph Jimenez, CEO of Novartis, said: “Novartis had a strong quarter for innovation, with US approval and launch of both Entresto and Glatopa being key highlights. Additionally, we reported a broad range of positive clinical data across franchises, including Tafinlar/Mekinist in metastatic melanoma and Cosentyx in ankylosing spondylitis. We are confident we will deliver on our priorities for the year, and confirm our full-year guidance.”

  • Sales, core[1] operating income and core EPS grew …
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Sandoz launches the Balans programme in Central and Eastern Europe to promote healthier living

  • The Balans programme focuses on educating patients about the benefits of probiotics, which help our digestive tract to metabolize the food we consume, maintain the health of our intestines, and support the function of our immune system.
  • The use of probiotics presents a natural and safe way to keep the balance of our intestinal microbiota, which is important for our well-being.
  • The Balans programme complements the 30 years of experience Sandoz has in the field of microbiotics and its strong line of Linex probiotic products.

Holzkirchen, Germany, July …

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