{"id":44447,"date":"2021-10-21T15:15:01","date_gmt":"2021-10-21T19:15:01","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=44447"},"modified":"2021-10-25T16:12:17","modified_gmt":"2021-10-25T20:12:17","slug":"cyltezo-fda-approval","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/cyltezo-fda-approval\/","title":{"rendered":"FDA approves Cyltezo, the first interchangeable biosimilar to Humira"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">On Oct. 15, the U.S. Food and Drug Administration (FDA) approved Cyltezo, the first interchangeable biosimilar to <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/humira\/what-is\"><span style=\"font-weight: 400;\">Humira<\/span><\/a><span style=\"font-weight: 400;\">, which is the world\u2019s <\/span><a href=\"https:\/\/www.yahoo.com\/now\/abbvies-humira-still-number-1-224014673.html\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">top-selling drug<\/span><\/a><span style=\"font-weight: 400;\"> and the number one treatment for several inflammatory diseases.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">With the FDA\u2019s <\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-cyltezo-first-interchangeable-biosimilar-humira\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">decision<\/span><\/a><span style=\"font-weight: 400;\">, Cyltezo (adalimumab-adbm) can now be made available to patients with <a href=\"https:\/\/www.singlecare.com\/blog\/types-of-arthritis\/\">rheumatoid and psoriatic arthritis, ankylosing spondylitis<\/a>, <a href=\"https:\/\/www.singlecare.com\/conditions\/crohns-disease-treatment-and-medications\">Crohn\u2019s disease<\/a>, <a href=\"https:\/\/www.singlecare.com\/blog\/ulcerative-colitis-vs-crohns\/\">ulcerative colitis<\/a>, <a href=\"https:\/\/www.singlecare.com\/conditions\/psoriasis-treatment-and-medications\">plaque psoriasis<\/a>, and <a href=\"https:\/\/www.singlecare.com\/blog\/juvenile-arthritis\/\">juvenile idiopathic arthritis<\/a> who have a prescription for Humira (adalimumab). And this could signal a savings opportunity for those patients.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cThe biosimilar and interchangeable approval pathway was created to help increase access to treatment options for patients with serious medical conditions,\u201d said Acting FDA Commissioner Janet Woodcock, MD, in a statement. \u201cWe continue to be steadfast in our commitment to provide patients with alternative high-quality, affordable medications that are proven to be safe and effective.\u201d\u00a0\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">While Cyltezo is the first interchangeable biosimilar for Humira, it\u2019s the second interchangeable biologic ever approved by the administration. (The first was <\/span><a href=\"https:\/\/www.singlecare.com\/blog\/news\/semglee-insulin-biosimilars-fda-approval\/\"><span style=\"font-weight: 400;\">Semglee<\/span><\/a><span style=\"font-weight: 400;\">, a biosimilar insulin to Lantus, earlier this year). Biologics, or biological products, are produced from living organisms, such as animal or plant cells. They comprise the fastest growing segments of the prescription drug market, <\/span><a href=\"https:\/\/www.fda.gov\/drugs\/biosimilars\/biosimilar-and-interchangeable-products\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">according to the FDA<\/span><\/a><span style=\"font-weight: 400;\">, but some remain very expensive. Approval of interchangeable biosimilar medications will help open the door to lower-cost treatment options for patients.<\/span><\/p>\n<p><b>RELATED: <\/b><a href=\"https:\/\/www.singlecare.com\/blog\/biologics-for-psoriasis\/\"><b>What you should know about biologics for psoriasis<\/b><\/a><\/p>\n<h2><span style=\"font-weight: 400;\">What is Cyltezo?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Cyltezo is a <\/span><a href=\"https:\/\/www.singlecare.com\/drug-classes\/monoclonal-antibodies\"><span style=\"font-weight: 400;\">monoclonal antibody<\/span><\/a><span style=\"font-weight: 400;\"> used to treat a range of inflammatory diseases. Like Humira it is a TNF-alpha inhibitor, which works by suppressing the body\u2019s response to an inflammatory protein produced by white blood cells.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Cyltezo is used to treat the following conditions in adults:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">moderate to severe rheumatoid arthritis<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">psoriatic arthritis<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">ankylosing spondylitis<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">moderate to severe Crohn\u2019s disease<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">moderate to severe ulcerative colitis<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">moderate to severe chronic plaque psoriasis<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Cyltezo can also be used to treat children with moderate to severe polyarticular juvenile idiopathic arthritis.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The drug was initially approved by the FDA in 2017, but will not be available in pharmacies until July of <\/span><a href=\"https:\/\/www.ajmc.com\/view\/could-cyltezo-be-the-first-interchangeable-biosimilar-in-the-united-states-\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">2023<\/span><\/a><span style=\"font-weight: 400;\">. It is a subcutaneous injection and comes in single-dose, pre-filled glass syringes (40 mg\/0.8 mL and 20 mg\/0.4 mL).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The most common side effects are upper respiratory and sinus infections, injection site reactions, headache, and rash. The most serious known side effects are an increased chance of infections that could lead to hospitalization or death, and the development of some cancers, including lymphoma. (The same <\/span><a href=\"https:\/\/www.singlecare.com\/blog\/humira-side-effects\/\"><span style=\"font-weight: 400;\">side effects occur with use of Humira<\/span><\/a><span style=\"font-weight: 400;\">.)<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">How does Cyltezo compare to Humira?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">The FDA reviews proposed biosimilars and determine if they are similar enough to existing biologics to be approved for use for the same conditions. In order to get a FDA-treatment approved as a biosimilar, a manufacturer must demonstrate that its product is highly similar in structure and function to the reference product (in this case Humira), and that it leads to the same clinical outcomes.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Cyltezo was approved as a biosimilar in <\/span><span style=\"font-weight: 400;\">2017<\/span><span style=\"font-weight: 400;\"> for all but two of the conditions Humira is used for (hidradenitis suppurativa and uveitis). Humira is also approved for Crohn\u2019s disease and ulcerative colitis in children, while Cyltezo is only approved for adults with those conditions.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">This latest approval follows <\/span><span style=\"font-weight: 400;\">additional testing<\/span><span style=\"font-weight: 400;\">, which showed that Cyltezo produces the same clinical results in any given patient, which qualifies it to be considered interchangeable with Humira.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">How Cyltezo helps with Humira cost<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">The FDA has approved <\/span><span style=\"font-weight: 400;\">29 biosimilar products<\/span><span style=\"font-weight: 400;\">, but this is only the second time the agency has bestowed interchangeable approval on a biosimilar. This certification means that pharmacists can fill a patient\u2019s prescription for Humira with Cyltezo instead, without consulting a physician\u2014similar to how generic drugs can be dispensed in place of their more expensive brand name counterparts. In the same way, the move to this Humira alternative could dramatically bring down the cost of treatment. Biosimilars can cost 15% to 35% less than their reference products.<\/span><\/p>\n<p><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.singlecare.com\/prescription\/humira\">Humira<\/a> has been the world\u2019s highest grossing medication <\/span><a href=\"https:\/\/www.fiercepharma.com\/special-report\/top-20-drugs-by-2020-sales-humira\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">for almost a decade<\/span><\/a><span style=\"font-weight: 400;\">, bringing in $20.4 billion in sales last year. It is a very expensive drug: It costs <\/span><a href=\"https:\/\/www.singlecare.com\/blog\/humira-cost\/\"><span style=\"font-weight: 400;\">$7,389 for two subcutaneous kits (10 mg\/0.1 mL)<\/span><\/a><span style=\"font-weight: 400;\">, which is about one month\u2019s supply. And the price is only increasing. A 2021 House Committee on Oversight <\/span><a href=\"https:\/\/endpts.com\/house-committee-uncovers-how-humiras-price-spiked-by-470-as-abbvie-execs-cashed-bonuses-tied-to-the-hikes\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">report<\/span><\/a><span style=\"font-weight: 400;\"> found that the price of Humira was hiked up more than a dozen times since 2013, and now costs patients $77,586 a year, \u201ca 470% increase from when the drug entered market\u201d in 2003.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">When it comes on the market on Jul. 1, 2023, Cyltezo costs should be far less than that for the millions of people living with inflammatory bowel disease, rheumatoid arthritis, and other related conditions. If Humira or Cyltezo are still expensive with insurance, you can use a <\/span><a href=\"https:\/\/www.singlecare.com\/prescription-discount-card\"><span style=\"font-weight: 400;\">free prescription discount card<\/span><\/a><span style=\"font-weight: 400;\"> from SingleCare on your prescription to save up to 80%.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On Oct. 15, the U.S. Food and Drug Administration (FDA) approved Cyltezo, the first interchangeable biosimilar to Humira, which is the world\u2019s top-selling drug and the number one treatment for several inflammatory diseases.\u00a0 With the FDA\u2019s decision, Cyltezo (adalimumab-adbm) can now be made available to patients with rheumatoid and psoriatic arthritis, ankylosing spondylitis, Crohn\u2019s disease, [&hellip;]<\/p>\n","protected":false},"author":94,"featured_media":6927,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4114],"tags":[4141,3418],"coauthors":[10392],"class_list":["post-44447","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-fda-approvals","tag-generic-drugs","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA approves Cyltezo, a Humira alternative | SingleCare<\/title>\n<meta name=\"description\" content=\"Cyltezo, the first interchangeable biosimilar to Humira, is approved by the FDA. 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