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news.The US Food and Drug Administration (FDA) has accepted Sandoz's regulatory submission for Etanercept, a biosimilar to Amgen's Enbrel drug.
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Etanercept is a tumor necrosis factor alpha (TNF-alpha) inhibitor used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis.
Sandoz head of global biopharmaceutical & oncology injectables development Mark McCamish said: "anti-TNFs will continue to play a leading role in immunology treatment and the acceptance of our regulatory submission by the FDA today is a significant step towards increasing patient access to these life-changing medicines."
It is the second biologics license application (BLA) submission by Sandoz using the 351(k) biosimilar pathway.
The BLA includes a data package that features data from analytical, functional, pre-clinical and clinical studies.
Sandoz, the generic pharmaceuticals division of Novartis, believes that both the pivotal clinical studies will show that the planned biosimilar is similar to the reference product.
Sandoz recently launched Zarxio (filgrastim-sndz), the first biosimilar in the US. The company has pipeline with various biosimilars in several stages of development including five programs in Phase III clinical trials or registration preparation.
The company intends to make ten regulatory submissions over the next three years.
Sandoz provides a portfolio of about 1 100 high-quality molecules, which ranges from standard generics to complex products.
The company employs about 26 500 people globally with over ten development centers and a network of more than 30 manufacturing sites.