Bioequivalence endpoints met in study of biosimilar rituximab - 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 II rituximab trial demonstrated PK bioequivalence and similar PD, safety, efficacy and immunogenicity between the biosimilar candidate and the rituximab originator product (MabThera). Adverse events related to both products were similar for both medicines.This was a prospective, randomized, double blind study in 173 patients with active rheumatoid arthritis not responsive to conventional therapies (disease-modifying antirheumatic drugs or TNF inhibitors). Primary analysis was performed at week 24 with efficacy and PD data collected to week 52, with safety follow-up ending 24 weeks after the last administration of study medication.

Comment: The biosimilar rituximab candidate was accepted by the EMA for regulatory review in May 2016. Sandoz is seeking approval for the same indications as the reference product with the same presentations which is used to treat autoimmune diseases such as rheumatoid arthritis as well as a number of hematological cancers.

Comment:Rituximab patent expiry is 22 September 2016 in the US and in the EU the patents expired on 12 November 2013.