New data reinforces clinical basis for switching to Sandoz biosimilar medicines

  • Sandoz strengthens position as global leader in biosimilars with new immunology data from four clinical studies for proposed biosimilars adalimumab and rituximab
  • Efficacy and safety of biosimilar adalimumab and safety of biosimilar rituximab match reference medicines in multiple-switching and retreatment study respectively
  • Sandoz biosimilar adalimumab is under EMA review, while EC-approved Sandoz biosimilar rituximab is under review by the FDA

Holzkirchen, November 14, 2017- Sandoz, a Novartis division and the global leader in biosimilars, today announces data from four clinical studies comparing its proposed biosimilar adalimumab and biosimilar rituximab with their reference medicines, Humira * and MabThera /Rituxan ** respectively - .

Studies included two innovative trials involving switching and two pharmacokinetic (PK) and pharmacodynamic (PD) studies. The results were presented at the American College of Rheumatology (ACR) Annual Meeting in San Diego, US.

Innovative studies involving switching:

  • A Phase III confirmatory efficacy and safety study met its primary endpoint in the proportion of patients who achieved a 75% improvement at Week 16, as measured by the Psoriasis Area and Severity Index (PASI) . Further the impact of switching between Sandoz biosimilar adalimumab and its reference medicine in patients with moderate-to-severe chronic plaque psoriasis was assessed. This innovative study design included continuous and ’switch’ treatment arms. The study confirmed no clinically meaningful differences in efficacy, safety and immunogenicity between patients who continuously received biosimilar adalimumab, those who continuously received the reference medicine and those who switched between biosimilar adalimumab and reference medicine on multiple occasions.
  • A Phase III study evaluated rituximab retreatment in patients with rheumatoid arthritis (RA), who already had received reference rituximab for treatment of RA in the past. The study demonstrated that Sandoz biosimilar rituximab and the reference medicines match in terms of safety and immunogenicity for patients who switched from the reference medicine to biosimilar rituximab and for those who continued treatment with the reference medicine.

"Healthcare systems have a significant opportunity to deliver much-needed savings by switching to high-quality biosimilars," said Mark Levick, MD PhD, Global Head of Development, Biopharmaceuticals, Sandoz. "Not only does the data presented demonstrate that our biosimilar adalimumab and biosimilar rituximab are important biologic alternatives for patients, but that physicians can switch to our biosimilars with confidence."

PK and PD data demonstrating equivalence:

  • The Phase I PK study met its primary endpoint as bioequivalence was demonstrated between the biosimilar adalimumab and the reference medicine. The study demonstrated that Sandoz biosimilar adalimumab matched the reference adalimumab in terms of safety, tolerability and immunogenicity.
  • The confirmatory PK and PD study in patients with RA met its primary endpoint by demonstrating PK bioequivalence and PD equivalence of biosimilar rituximab and the reference medicine. Study results further demonstrated the medicines have matching efficacy, safety and immunogenicity profiles.

Sandoz is committed to increasing patient access to high-quality biosimilars. We are the global leader in biosimilars, with five biosimilars currently marketed in various countries, as well as a leading global pipeline. Sandoz biosimilar rituximab, marketed as Rixathon , was approved by the European Commission (EC) in June 2017 and is currently under review by the US Food and Drug Administration (FDA). Sandoz biosimilar adalimumab is currently being reviewed by the European Medicines Agency (EMA).

Sandoz is well positioned to continue leading the biosimilars industry based on our experience and capabilities in development, manufacturing and commercialization. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, we benefit strongly from this unique blend of experience and expertise in many different market environments.

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