Sandoz, a Novartis company and the global leader in biosimilars,
announced today that the US Food and Drug Administration (FDA) has
accepted its Biologics License Application (BLA) under the 351 (k)
pathway for its proposed biosimilar to Amgen's US-licensed Enbrel®*
(etanercept) - a tumor necrosis factor alpha (TNF-alpha) inhibitor.
Sandoz 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 affecting approx.
1.3 million and 7.5 million people (respectively) in the US.
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 has an unwavering commitment to increasing patient access to
high-quality, life-enhancing biosimilars. It is the pioneer and global
market leader and currently markets three biosimilars. Sandoz recently
launched ZarxioTM (filgrastim-sndz) - the first biosimilar in
the United States, 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 three 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.
