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Applications for proposed first-of-a-kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA
  • Submission of proposed biosimilar supported by comprehensive package; aims to expand treatment access for people with multiple sclerosis in US and EU
     
  • Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease that can drastically affect an individual’s everyday life and requires life-long treatment
     
  • Sandoz is committed to accelerating patient access to potentially life-changing, high-quality treatments, while generating savings for healthcare systems and patients

Basel, July 25, 2022 …

Sandoz Supplemental Biologics License Application accepted by US FDA for biosimilar Hyrimoz® (adalimumab-adaz) high concentration formulation (HCF)
  • Submission supported by comprehensive analytical data package and clinical Phase I pharmacokinetics bridging study
     
  • Proposed Hyrimoz® HCF would help expand access to medicine for patients with chronic immune-mediated inflammatory diseases
     
  • Sandoz is committed to supporting healthcare professionals to advance patient care and improve access to medicines sustainably and affordably
     

Basel, July 21, 2022 – Sandoz, a global leader in generic and biosimilar medicines, today …

Novartis delivers continued strong momentum of key growth brands, progress on strategic initiatives and confirms FY’22 Group guidance

Ad hoc announcement pursuant to Art. 53 LR

  • Q2 sales grew +5% cc1 (-1% USD)
    • Innovative Medicines (IM) sales grew +5% cc (-1% USD); strong performance of key growth brands including Entresto (+33% cc), Kesimpta (+270% cc), Cosentyx (+12% cc), Kisqali (+43% cc) and Zolgensma (+26% cc)
    • Sandoz sales grew +5% cc (-3% USD) benefiting from a return towards normal business dynamics, with growth across all business …
Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA
  • Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study
  • Adalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced yet familiar experience for patients
  • Submission builds on Sandoz’ well established biosimilar immunology portfolio in Europe

Basel, June 17, 2022 — Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration  …

HEXAL launches Dimethyl fumarate HEXAL® a generic drug for Tecfidera®, in Germany, offering an economically efficient treatment option for the care of adult patients with multiple sclerosis*
  • Dimethyl fumarate HEXAL® is bioequivalent to the originator product 1,2,3
  • Additional 196 pack size reduces co-payment burden for patients

Basel, June 10, 2022 — Sandoz expands its portfolio and today announces the launch of the generic drug Dimethyl fumarate HEXAL®, which  is approved for the treatment of adults with relapsing remitting  multiple sclerosis  (RRMS) 1, in Germany.

“We are proud to introduce a generic drug for German patients for the treatment of …

Sandoz announces new global ‘Act4Biosimilars’ initiative, to improve patient access and increase adoption by at least 30% in 30+ countries by 2030
  • Multidisciplinary Steering Committee established to drive action includes patient advocacy leaders, healthcare professionals, biosimilar experts and industry leaders
     
  • Action Plan will provide roadmap and tools to improve approvability, accessibility, acceptability and affordability (4As) of biosimilars
     
  • Sandoz launched initiative to support improved healthcare access, equity and sustainability

Basel, May 31, 2022 – Sandoz, a global leader in generic and biosimilar medicines, today …

Sandoz appoints new Board representative to global AMR Industry Alliance
  • Dr. Boumediene Soufi, global head of Sandoz AMR (antimicrobial resistance) program, to represent Sandoz as Board member of AMR Industry Alliance (AMRIA)
  • The Alliance brings together about 100 life science companies / associations in search of sustainable solutions to curb AMR
  • Sandoz, as largest global provider of generic antibiotics1, is committed to a pragmatic and balanced …
Sandoz launches first generic pirfenidone in US for patients with idiopathic pulmonary fibrosis, growing its respiratory portfolio
  • Pirfenidone is used to treat idiopathic pulmonary fibrosis (IPF),1 a progressive disease that causes irreversible lung scarring and makes it difficult to breathe2
  • Approximately 140,000 Americans live with IPF, a rare disease with no cure, and 50,000 new cases are diagnosed annually3
  • Sandoz is committed to developing and providing patient access to high-quality, more affordable generic medicines, especially in areas of high unmet need

Princeton, May 12, 2022 — Sandoz, a global leader in …