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Posted 1 Sep 2016 by Drugs.com
August 30, 2016 – The U.S. Food and Drug Administration today approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998. Erelzi is administered by injection for the treatment of: moderate to severe rheumatoid arthritis, either as a standalone therapy or in combination with methotrexate (MTX); moderate to severe polyarticular juvenile idiopathic arthritis in patients ages two and older; active psoriatic arthritis, including use in combination with MTX in psoriatic arthritis patients who do not respond adequately to MTX alone; active ankylosing spondylitis (an arthritis that affects the spine); and chronic moderate to severe plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy. Health care professionals should review the prescribing ... Read more
Posted 31 Aug 2016 by Drugs.com
WEDNESDAY, Aug. 31, 2016 – A new biological drug to treat rheumatoid arthritis and other inflammatory diseases has been approved by the U.S. Food and Drug Administration. The drug Erelzi (etanercept-szzs) is a "biosimilar" to Enbrel (etanercept), which was approved by the FDA in 1998. A biosimilar is a biological product approved on findings that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety and effectiveness, according to the FDA. It is similar to generic drugs in that it typically costs less than the original biological product. Biological products are typically derived from a living organism and include many sources, including humans, animals, microorganisms or yeast. "The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases," ... Read more