New data reinforces clinical basis for switching to Sandoz biosimilar medicines - Seite 2

 

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[2].

"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[3].
• 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[4].

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)[6] 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).