The FDA has accepted its Biologics License Application (BLA) under the 351(k) pathway for Sandoz’s proposed biosimilar to Amgen’s U.S.-licensed Enbrel (etanercept)—a tumor necrosis factor alpha (TNF-alpha) inhibitor. Sandoz, a Novartis company, is seeking approval for all indications included in the label of the reference product, which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis affectingabout 1.3 million and 7.5 million people (respectively) in the U.S.
Mark McCamish, M.D., Ph.D., and head of global biopharmaceutical and oncology injectables development at Sandoz, said, “We believe we are the first company to receive FDA file acceptance of a biosimilar version of etanercept.”
The BLA submission is the second 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 U.S., signaling a shift toward more competition and affordability in the healthcare system. Sandoz has a 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 10 regulatory submissions in the next three years.