Sandoz receives positive CHMP opinion for proposed biosimilar adalimumab

  • Sandoz is seeking approval of proposed biosimilar adalimumab for use in all reference medicine indications including those in rheumatology, gastroenterology and dermatology
  • Positive CHMP opinion based on comprehensive analytical, preclinical and clinical data package that shows proposed biosimilar adalimumab matches reference medicine
  • This recommendation marks the fourth positive CHMP opinion for a Sandoz biosimilar within 18 months

Holzkirchen, June 1, 2018 – Sandoz, a Novartis division and the global leader in biosimilars, …

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Sandoz receives positive CHMP opinion for proposed biosimilar adalimumab

  • Sandoz is seeking approval of proposed biosimilar adalimumab for use in all reference medicine indications including those in rheumatology, gastroenterology and dermatology
  • Positive CHMP opinion based on comprehensive analytical, preclinical and clinical data package that shows proposed biosimilar adalimumab matches reference medicine
  • This recommendation marks the fourth positive CHMP opinion for a Sandoz biosimilar within 18 months

Holzkirchen, June 1, 2018 – Sandoz, a Novartis division and the global leader in biosimilars, …

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Sandoz receives European Commission approval for Zessly® (infliximab) in gastroenterological, rheumatological and dermatological diseases

Sandoz receives European Commission approval for Zessly® (infliximab) in gastroenterological, rheumatological and dermatological diseases

  • European Commission’s (EC) approval based on comprehensive data package confirming that Zessly® matches safety, efficacy and quality of reference medicine
  • Biosimilars such as Zessly enable earlier patient access to important medicines and positively impact healthcare systems
  • Zessly is the third EC approval for a Sandoz biosimilar in 12 months …
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Sandoz receives European Commission approval for Zessly® (infliximab) in gastroenterological, rheumatological and dermatological diseases

Sandoz receives European Commission approval for Zessly® (infliximab) in gastroenterological, rheumatological and dermatological diseases

  • European Commission’s (EC) approval based on comprehensive data package confirming that Zessly® matches safety, efficacy and quality of reference medicine
  • Biosimilars such as Zessly enable earlier patient access to important medicines and positively impact healthcare systems
  • Zessly is the third EC approval for a Sandoz biosimilar in 12 months …
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Sandoz receives complete response letter from the US FDA for proposed biosimilar rituximab

Holzkirchen, May 2, 2018 — Sandoz, a Novartis division, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab.

Sandoz stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter. While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible.

There is a …

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Sandoz receives complete response letter from the US FDA for proposed biosimilar rituximab

Holzkirchen, May 2, 2018 — Sandoz, a Novartis division, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab.

Sandoz stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter. While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible.

There is a …

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Novartis delivered a strong first quarter and acted to become a more focused medicines company

  • Net sales grew 4% (cc[1], +10% USD) mainly driven by:
    • Entresto grew to USD 200 million, +126% (cc) driven by increased uptake world wide
    • Cosentyx was USD 580 million, +35% (cc) with strong growth in all indications and expanded access
    • Oncology returned to growth (+6% cc) driven by Promacta/Revolade, Tafinlar + Mekinist, Jakavi and recent launches
  • Core[1] operating income grew 4% (cc, +11% USD) as higher sales helped support growth and launch investments; Core EPS of USD 1.28, …
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Novartis delivered a strong first quarter and acted to become a more focused medicines company

  • Net sales grew 4% (cc[1], +10% USD) mainly driven by:
    • Entresto grew to USD 200 million, +126% (cc) driven by increased uptake world wide
    • Cosentyx was USD 580 million, +35% (cc) with strong growth in all indications and expanded access
    • Oncology returned to growth (+6% cc) driven by Promacta/Revolade, Tafinlar + Mekinist, Jakavi and recent launches
  • Core[1] operating income grew 4% (cc, +11% USD) as higher sales helped support growth and launch investments; Core EPS of USD 1.28, …
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Sandoz signs agreement with Pear Therapeutics to develop and commercialize prescription digital therapeutics for patients with substance use disorder and opioid use disorders

  • Deal includes reSET®, cleared by FDA for treatment of patients with Substance Use Disorder, and reSET-O™, potential treatment pending FDA clearance for patients with Opioid Use Disorder treated with buprenorphine 
  • Combines Sandoz expertise in launching / commercializing treatments with Pear’s expertise in developing prescription digital therapeutics 
  • Sandoz and Novartis continue to embrace emerging digital technologies to enhance R&D and deliver better outcomes for patients

…

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Sandoz signs agreement with Pear Therapeutics to develop and commercialize prescription digital therapeutics for patients with substance use disorder and opioid use disorders

  • Deal includes reSET®, cleared by FDA for treatment of patients with Substance Use Disorder, and reSET-O™, potential treatment pending FDA clearance for patients with Opioid Use Disorder treated with buprenorphine 
  • Combines Sandoz expertise in launching / commercializing treatments with Pear’s expertise in developing prescription digital therapeutics 
  • Sandoz and Novartis continue to embrace emerging digital technologies to enhance R&D and deliver better outcomes for patients

…

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