Bioequivalence endpoints met in study of biosimilar etanercept.- Sandoz

Sandoz has 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. Rituximab is also indicated to treat hematological cancers like follicular lymphoma.

The Phase I etanercept trial demonstrated PK bioequivalence and no clinically meaningful differences in safety, tolerability and immunogenicity between the biosimilar candidate and the etanercept originator product (Enbrel). No major safety signals were observed during the study.This study was a randomized, two-way crossover trial comparing the PK and safety of Sandoz' biosimilar etanercept candidate with originator etanercept (Enbrel) in 54 healthy subjects, with a washout period of at least 35 days between administration of the two study drugs. Follow-up was undertaken for four weeks after the final study drug administration.

Comment: Sandoz' biosimilar etanercept was accepted by the FDA and EMA for regulatory review in the last quarter of 2015. Sandoz is seeking approval for all indications included in the label of the originator product, which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis.

Comment: The US patent for Enbrel was originally set to expire in October 2012 but a 16 year extension brought that date to 2028. The EU patent expired in February 2015.