MarketWatch (10/02/15)

The U.S. Food and Drug Administration (FDA) has accepted Sandoz's Biological License Application (BLA) under the 351 (k) pathway for the company's proposed biosimilar to Amgen's Enbrel (etanercept). Enbrel is a tumor necrosis factor alpha (TNF-alpha) inhibitor that is used to treat a number of autoimmune diseases, including rheumatoid arthritis and psoriasis. The application seeks approval for all indications included on the reference product's label. Sandoz's Mark McCamish, MD, PhD, noted that "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." Sandoz says that two key clinical trials--a pharmokinetic study in healthy volunteers and a confirmatory safety and efficacy study in patients with chronic plaque-type psoriasis--will demonstrate its product's similarity to the reference product. The company, a unit of Novartis, recently launched Zarxio (filgrastim-sndz)--the first biosimilar in the United States--and it plans to make ten regulatory submissions over the next three years.

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