New data demonstrates Sandoz’ etanercept and rituximab biosimilar candidates bioequivalent to originator products

Sandoz' biosimilar etanercept candidate shows pharmacokinetic (PK) bioequivalence with no clinically meaningful differences in safety, tolerability and immunogenicity to the originator. Sandoz' biosimilar rituximab candidate shows PK bioequivalence  and similar pharmacodynamics (PD), safety, efficacy and immunogenicity. Biosimilar etanercept candidate is under regulatory review by EMA* and FDA** and biosimilar rituximab candidate is undergoing EMA review. Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, today announced results from two key studies comparing its  biosimilar etanercept and rituximab candidates with the originator products - Enbrel ^*** and MabThera ^**** respectively. In both studies, the primary endpoints of achieving PK bioequivalence were met. The studies were presented at the Annual European Congress of Rheumatology (EULAR 2016) in London. Etanercept and rituximab are indicated to treat autoimmune diseases such as rheumatoid arthritis.