FDA Approves Humira Biosimilar Cyltezo for Ulcerative Colitis, Crohn’s Disease, Other Illnesses

FDA Approves Humira Biosimilar Cyltezo for Ulcerative Colitis, Crohn’s Disease, Other Illnesses
The U.S. Food and Drug Administration (FDA) has approved Boehringer Ingelheim's Cyltezo— a biosimilar of Abbvie's Humira (adalimumab) — to treat Crohn's disease, ulcerative colitis and a host of other diseases ranging from rheumatoid arthritis to ankylosing spondylitis. Cyltezo is the German company's 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 Ingelheim's therapeutic area biosimilars, said in a press release. The FDA's Aug. 29 decision is the second biosimilar of Humira after the approval of Amgen's Amjevita in September 2016. Another biosimilar of Humira, Imraldi by 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 th
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