The U.S. Food and Drug Administration(FDA) has approved Boehringer IngelheimsCyltezo a biosimilar of Abbvies Humira (adalimumab) to treat Crohns disease,ulcerative colitis and a host of other diseases ranging from rheumatoid arthritis toankylosing spondylitis. Cyltezo is the German companys first FDA-approved biosimilar and marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients, Ivan Blanarik, senior vice-president and head of Boehringer Ingelheims therapeutic area biosimilars, said in a press release. The FDAs Aug. 29 decision is thesecond biosimilar of Humira after the approval of AmgensAmjevitain September 2016. Another biosimilar of Humira, Imraldiby Samsung Bioepis, won approval by the European Medicines Agency (EMA) on Aug. 24. The FDA granted its approval based on pharmacological, non-clinical and clinical data showing that Cyltezo is a biosimilar of Humira. The EMA is also expected to provide an opinion this year. A biosimilar is a drug that is shown to be highly similar to another existing biological drug, according to the FDA. It should have no clinically meaningful differences in terms of safety and effectiveness from the reference product. It is usually manufactured by a concurrent company after the patent for the original product has expired. … Continue reading
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