FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept

Sandoz is seeking approval for all indications included in the reference product's label.

Mark McCamish, Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz said: "Anti-TNFs will continue to play a leading role in immunology treatment and the acceptance of our regulatory submission by the FDA is a significant step towards increasing patient access to these life-changing medicines." McCamish continued: "We believe we are the first company to receive FDA file acceptance of a biosimilar version of etanercept."

This is the second BLA submission by Sandoz using the 351(k) biosimilar pathway. The BLA consists of a comprehensive data package that includes data from analytical, functional, pre-clinical and clinical studies. Sandoz believes that the two pivotal clinical studies; a pharmacokinetic (PK) study in healthy volunteers (HVs) and a confirmatory safety and efficacy study in patients with chronic plaque-type psoriasis (EGALITY), will provide confirmation of similarity to the reference product established in prior analytical comparability investigations.

Sandoz currently markets three biosimilars. Sandoz recently launched Zarxio (filgrastim-sndz) — the first biosimilar in the US, signaling a shift toward more competition and affordability in the healthcare system. Sandoz has a leading pipeline with several biosimilars across the various stages of development including five programs in Phase III clinical trials or registration preparation. The company plans to make ten regulatory submissions in the next 3 years. As part of the Novartis Group, Sandoz is uniquely positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.