{"id":797,"date":"2024-07-31T13:32:08","date_gmt":"2024-07-31T13:32:08","guid":{"rendered":"http:\/\/sshop.me\/?p=797"},"modified":"2024-08-01T10:48:20","modified_gmt":"2024-08-01T10:48:20","slug":"copycat-weight-loss-drugs-are-major-players-with-consumers","status":"publish","type":"post","link":"http:\/\/sshop.me\/index.php\/2024\/07\/31\/copycat-weight-loss-drugs-are-major-players-with-consumers\/","title":{"rendered":"Copycat Weight-Loss Drugs Are Major Players With Consumers"},"content":{"rendered":"

As many as 1<\/strong> in 8<\/strong> American adults has tried<\/a> one of the GLP-1 anti-obesity drugs, but a surprising number aren\u2019t getting their supplies from pharma giants Novo Nordisk <\/strong>or Eli Lilly<\/strong>. Up to 30 percent <\/strong>of the market, by some estimates, is made up of copycat versions from compounding pharmacies.<\/p>\n

Compounding is legal, though the resulting products sometimes fall into a gray area because they\u2019re copies of drugs under patent and are not approved by the Food and Drug Administration<\/strong>.<\/p>\n

Mark Mikhael<\/strong>, CEO of Orlando-based Olympia Pharmaceuticals<\/strong>, estimates that his and other large compounders provision up to 2 million<\/strong> Americans each month with semaglutide, the scientific name for Novo Nordisk\u2019s Wegovy, Ozempic and Rybelsus formulations, or tirzepatide, the active ingredient in Eli Lilly\u2019s Zepbound and Mounjaro.<\/p>\n

Many of the compounded drugs are produced for and sold by online pharmacies like Hims & Hers Health<\/strong>, Henry Meds<\/strong> and Ro<\/strong>. Others come from smaller compounding companies.<\/p>\n

Novo Nordisk and Lilly fiercely oppose these sales and lump the compounders together with unregulated medical spas peddling bogus semaglutide. Novo Nordisk has filed at least 21 lawsuits <\/strong>nationwide against companies making purported copies of its drugs, said Brianna Kelley<\/strong>, a spokesperson for the company, and urges doctors to avoid them.<\/p>\n

When there\u2019s a drug shortage \u2014 the FDA has put semaglutide and tirzepatide on shortage lists since 2022 \u2014 the agency allows compounders to make it. The compounding companies get raw material for the drugs from mostly Chinese businesses that are registered and, at least in theory, inspected by the FDA.<\/p>\n

Because the drugs are not strictly FDA-approved, those who make, prescribe or take them should exercise \u201can increased level of responsibility or awareness,\u201d FDA spokesperson Amanda Hils <\/strong>said.<\/p>\n

But she distinguished the compounded drugs from unregulated powders sold as \u201cgeneric Ozempic\u201d and the like, which may be contaminated or counterfeit. The agency recently warned about patients taking the wrong doses<\/a> of the compounds, but it hasn\u2019t received a disproportionate number of side effect reports linked to these drugs.<\/p>\n

Semaglutide and tirzepatide have registered unprecedented success in weight loss. They are also showing promise against heart, kidney and liver diseases, and are being tested to treat or prevent Alzheimer\u2019s disease and drug addiction. It\u2019s no wonder they are in shortage.<\/p>\n

While most compounded drugs are copies of old, cheap generics, semaglutide and tirzepatide are under patent and earn Novo Nordisk and Lilly billions of dollars a year. Compounded forms are cheaper, particularly for patients whose insurers won\u2019t cover the branded drugs.<\/p>\n

While the pharmaceutical giants can\u2019t keep up with demand, they dispute the right of compounders to make and sell copies. Lilly spokesperson Kristiane Silva Bello<\/strong> said her company was \u201cdeeply concerned\u201d about \u201cserious health risks\u201d from compounded drugs that \u201cshould not be on the market.\u201d<\/p>\n

Mikhael\u2019s company is an outsourcing facility, or 503B compounding pharmacy \u2014 regulated directly by the FDA. Smaller 503A pharmacies are largely overseen by state boards of pharmacy.<\/p>\n

The compounders are defiant, calling the diabetes and diet drugs essential products.<\/p>\n

\u201cIf you don\u2019t want a 503B facility to make a copy, it\u2019s pretty simple: Don\u2019t go short,\u201d said Lee Rosebush<\/strong>, chair of a trade association for 503B pharmacies. \u201cFDA created this system because these are necessary drugs.\u201d<\/p>\n

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org<\/a>.<\/em><\/p>\n

KFF Health News<\/a> is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF\u2014an independent source of health policy research, polling, and journalism. Learn more about KFF<\/a>.<\/p>\n

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This story can be republished for free (details<\/a>).<\/p>\n","protected":false},"excerpt":{"rendered":"

As many as 1 in 8 American adults has tried one of the GLP-1 anti-obesity drugs, but a surprising number aren\u2019t getting their supplies from pharma giants Novo Nordisk or Eli Lilly. Up to 30 percent of the market, by some estimates, is made up of copycat versions from compounding pharmacies. Compounding is legal, though […]<\/p>\n","protected":false},"author":1,"featured_media":669,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14],"tags":[],"class_list":["post-797","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceuticals"],"_links":{"self":[{"href":"http:\/\/sshop.me\/index.php\/wp-json\/wp\/v2\/posts\/797"}],"collection":[{"href":"http:\/\/sshop.me\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/sshop.me\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/sshop.me\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/sshop.me\/index.php\/wp-json\/wp\/v2\/comments?post=797"}],"version-history":[{"count":1,"href":"http:\/\/sshop.me\/index.php\/wp-json\/wp\/v2\/posts\/797\/revisions"}],"predecessor-version":[{"id":798,"href":"http:\/\/sshop.me\/index.php\/wp-json\/wp\/v2\/posts\/797\/revisions\/798"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/sshop.me\/index.php\/wp-json\/wp\/v2\/media\/669"}],"wp:attachment":[{"href":"http:\/\/sshop.me\/index.php\/wp-json\/wp\/v2\/media?parent=797"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/sshop.me\/index.php\/wp-json\/wp\/v2\/categories?post=797"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/sshop.me\/index.php\/wp-json\/wp\/v2\/tags?post=797"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}