{"id":61184,"date":"2023-11-06T11:04:38","date_gmt":"2023-11-06T16:04:38","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=61184"},"modified":"2024-10-25T10:27:10","modified_gmt":"2024-10-25T14:27:10","slug":"fda-approval-wezlana","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/fda-approval-wezlana\/","title":{"rendered":"FDA approves Wezlana for inflammatory conditions"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">Those on immunosuppressive drugs for psoriasis or ulcerative colitis may soon breathe a little easier when they get to the pharmacy counter: The U.S. Food and Drug Administration (FDA) just <\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">approved<\/span><\/a><span style=\"font-weight: 400;\"> Wezlana (ustekinumab-auub), a biosimilar for the popular drug <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/stelara\/what-is\"><span style=\"font-weight: 400;\">Stelara<\/span><\/a><span style=\"font-weight: 400;\">. Manufactured by Amgen, the biosimilar&mdash;which is like a generic for biologic medications&mdash;was approved to treat inflammatory conditions like <\/span><a href=\"https:\/\/www.singlecare.com\/blog\/biologics-for-psoriasis\/\"><span style=\"font-weight: 400;\">plaque psoriasis<\/span><\/a><span style=\"font-weight: 400;\"> or <\/span><a href=\"https:\/\/www.singlecare.com\/conditions\/ulcerative-colitis-treatment-and-medications\"><span style=\"font-weight: 400;\">ulcerative colitis<\/span><\/a><span style=\"font-weight: 400;\">.&nbsp;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">While there is no meaningful difference between Wezlana vs. Stelara, the main differentiating factor will be the price. Biologic medications can be expensive, so Wezlana offers another treatment option and competition that will hopefully make the medications more affordable for patients.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">&ldquo;Biosimilar medications offer additional safe and effective treatment options that have the potential to increase access for people requiring treatment for inflammatory diseases,&rdquo; Nikolay Nikolov, MD, director of the Office of Immunology and Inflammation in the FDA&rsquo;s Center for Drug Evaluation and Research, explained in<\/span> <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">a statement<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<h2 id=\"what-is-wezlana\"><span style=\"font-weight: 400;\">What is Wezlana?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Ustekinumab is a type of immunosuppressive drug. It&rsquo;s a human <\/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;\"> that selectively targets interleukin (IL)-12 and IL-23, which are cytokines that play a role in tempering the body&rsquo;s inflammatory response in several medical conditions. This Stelara alternative is given by subcutaneous (under the skin) injection or intravenous (into a vein) infusion.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Wezlana treats the same conditions that Stelara has been approved to treat, including:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Moderate to severe plaque psoriasis in adults and children 6 and older<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Active psoriatic arthritis in adults and children 6 and older<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Moderate to severely active Crohn&rsquo;s disease in adults<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Moderate to severely active ulcerative colitis in adults<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The FDA approved Wezlana with an interchangeability designation. Meaning, pharmacists can swap Stelara for Wezlana when filling a prescription&mdash;without having to call their patients&rsquo; providers and ask them to make the change first.<\/span><\/p>\n<p><b>RELATED: <\/b><a href=\"https:\/\/www.singlecare.com\/blog\/ulcerative-colitis-vs-crohns\/\"><b>Ulcerative colitis vs. Crohn&rsquo;s disease<\/b><\/a><\/p>\n<h3 id=\"what-are-the-possible-side-effects-of-wezlana\"><span style=\"font-weight: 400;\">What are the possible side effects of Wezlana?<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">According to the FDA announcement, the most serious side effect of Wezlana is infection because the prescription affects your immune response. Other potential side effects include:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Upper respiratory infection<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Nasopharyngitis (common cold)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Headache<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Nausea, vomiting, and diarrhea<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Fatigue<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Injection site redness<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Vaginal yeast or fungal infection<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Bronchitis<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Itchiness<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Urinary tract infection<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Sinusitis<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Abdominal pain<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Fever&nbsp;<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Influenza<\/span><\/li>\n<\/ul>\n<h4 id=\"what-are-the-possible-side-effects-of-stelara\"><span style=\"font-weight: 400;\">What are the possible side effects of Stelara?<\/span><\/h4>\n<p><span style=\"font-weight: 400;\">When considering Wezlana, you may wonder: Does it have the same potential side effects as Stelara? In clinical studies, the <\/span><a href=\"https:\/\/www.stelarainfo.com\/crohns-disease\/about-stelara#slide-1\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">most common side effects of Stelara<\/span><\/a><span style=\"font-weight: 400;\"> were:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Nasal congestion, sore throat, and runny nose<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Upper respiratory infections<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Fever<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Headache<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Tiredness<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Itching<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Nausea, vomiting, and diarrhea<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Redness at the injection site<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Vaginal yeast infections<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Urinary tract infections<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Sinus infection<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Bronchitis<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Stomach pain<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Joint pain<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">In other words, the potential adverse effects are nearly identical to those of Wezlana.<\/span><\/p>\n<h2 id=\"when-will-wezlana-be-available\"><span style=\"font-weight: 400;\">When will Wezlana be available?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Amgen has not announced when Wezlana will be available. Earlier this year, Johnson &amp; Johnson, the manufacturer of Stelara,<\/span> <a href=\"https:\/\/www.centerforbiosimilars.com\/view\/amgen-s-stelara-biosimilar-delayed-until-2025-after-settling-with-j-j\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">settled a patent lawsuit against Amgen<\/span><\/a><span style=\"font-weight: 400;\"> for this medication. Reuters<\/span> <a href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/amgen-settles-jj-patent-lawsuit-over-drug-similar-blockbuster-stelara-2023-05-23\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">reported<\/span><\/a><span style=\"font-weight: 400;\"> that the settlement terms were confidential but would allow Amgen to begin selling its biosimilar of Stelara no later than January 1, 2025.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Other ustekinumab biosimilars may also eventually become available, as several are in the development pipeline.<\/span><\/p>\n<h2 id=\"how-much-will-wezlana-cost\"><span style=\"font-weight: 400;\">How much will Wezlana cost?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">The manufacturer of Wezlana has not yet released information about what the cost of Wezlana will be when it does reach the market.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Biologic drugs like Stelara are known for being effective but expensive. In fact, Stelara was one of 10 &ldquo;high-expenditure&rdquo;<\/span> <a href=\"https:\/\/www.ajmc.com\/view\/stelara-and-enbrel-chosen-for-ira-price-negotiation\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">drugs chosen for Medicare price negotiation<\/span><\/a><span style=\"font-weight: 400;\"> under the Inflation Reduction Act. The availability of the biosimilar Wezlana could save patients some money, as <\/span><a href=\"https:\/\/www.iqvia.com\/insights\/the-iqvia-institute\/reports-and-publications\/reports\/biosimilars-in-the-united-states-2023-2027\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">research<\/span><\/a><span style=\"font-weight: 400;\"> suggests that the introduction of biosimilars tends to drive down costs.&nbsp;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Xavier Becerra, the secretary of the U.S. Department of Health and Human Services, <\/span><a href=\"https:\/\/www.hhs.gov\/about\/news\/2023\/10\/31\/hhs-secretary-becerras-statement-fdas-approval-wezlana.html\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">praised<\/span><\/a><span style=\"font-weight: 400;\"> the approval of Wezlana for its potential to reduce drug spending for many consumers.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Those on immunosuppressive drugs for psoriasis or ulcerative colitis may soon breathe a little easier when they get to the pharmacy counter: The U.S. Food and Drug Administration (FDA) just approved Wezlana (ustekinumab-auub), a biosimilar for the popular drug Stelara. Manufactured by Amgen, the biosimilar&mdash;which is like a generic for biologic medications&mdash;was approved to treat [&hellip;]<\/p>\n","protected":false},"author":145,"featured_media":61186,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4589,4114],"tags":[72,4141,20955,15105],"coauthors":[9482],"class_list":["post-61184","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug-info","category-news","tag-fda","tag-fda-approvals","tag-inflammation","tag-skincare","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 Wezlana\u2014a Stelara alternative<\/title>\n<meta name=\"description\" content=\"Wezlana, an interchangeable biosimilar for Stelara, has been approved to treat plaque 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