{"id":36325,"date":"2014-07-08T09:05:33","date_gmt":"2014-07-08T13:05:33","guid":{"rendered":"http:\/\/asweetlife.org\/?post_type=feature&#038;p=36325"},"modified":"2016-01-11T03:48:18","modified_gmt":"2016-01-11T08:48:18","slug":"the-insulin-games-a-race-to-dominate-the-growing-market","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=36325","title":{"rendered":"The Insulin Games: A Race to Dominate the Growing Market"},"content":{"rendered":"<p style=\"text-align: center;\">\n<p style=\"text-align: justify;\">A new insulin that is very similar to Sanofi&#8217;s Lantus, the best selling insulin in the world, has been recommended for approval in Europe and is pending approval in the United States.<\/p>\n<p style=\"text-align: justify;\">The long-acting basal insulin developed by <a href=\"http:\/\/www.boehringer-ingelheim.com\/news\/news_releases\/press_releases\/2014\/27_june_2014_diabetes.html\">Boehringer Ingelheim and Eli Lilly and Company<\/a> received a positive opinion recommending approval by the European Committee for Medicinal Products for Human Use (CHMP). The insulin, called Abasria, has also been submitted for approval to the U.S. Food and Drug Administration, according to Dr. Gwen Krivi, Vice President of Development for Lily.<\/p>\n<p style=\"text-align: justify;\">Abasria is only one new insulin product being developed to try and capture a share of the growing insulin market overall. Sales of insulin reached almost $21 billion annually last year, according to <a href=\"http:\/\/www.grandviewresearch.com\/industry-analysis\/insulin-market\">Grand View Research<\/a>, a market research and consulting company.<\/p>\n<p style=\"text-align: justify;\">\u201cLilly\/BI\u2019s insulin glargine is a basal insulin, which is intended to provide long-lasting blood sugar control between meals and at night, an integral part of glycemic control,\u201d the companies said in a statement. \u201cIt has the same amino acid sequence as Lantus\u00ae (insulin glargine) and was filed through the European Medicines Agency\u2019s (EMA) biosimilar pathway.\u201d<\/p>\n<p style=\"text-align: justify;\">According to Lilly\/BI, Abasria is an \u201cinsulin glargine product, for the treatment of type 1 and type 2 diabetes\u201d and is the \u201cfirst biosimilar insulin recommended for approval in the European Union (EU).\u201d<\/p>\n<p style=\"text-align: justify;\"><a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/07\/Dr.-Gwen-Krivi.jpg\" rel=\"mfp\"><img decoding=\"async\" class=\"alignright size-full wp-image-36327 lazyload\" title=\"Dr. Gwen Krivi\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/07\/Dr.-Gwen-Krivi.jpg\" alt=\"Dr. Gwen Krivi\" width=\"200\" height=\"250\" \/><\/a>Biosimilar is a regulatory term meaning that the new insulin shares the same \u201cprimary amino acid structure\u201d as <a href=\"http:\/\/www.lantus.com\/\">Lantus<\/a>, Krivi said.<\/p>\n<p style=\"text-align: justify;\">\u201cAbasria is a biological medicinal product similar to the reference medicinal product Lantus (insulin glargine), authorised in the EU since 9 June 2000,\u201d <a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/medicines\/human\/medicines\/002835\/smops\/Positive\/human_smop_000706.jsp&amp;mid=WC0b01ac058001d127\">the EMA said in announcing its recommendation<\/a>. \u201cStudies have shown Abasria to have a comparable quality, safety and efficacy profile to Lantus (insulin glargine).\u201d<\/p>\n<p style=\"text-align: justify;\">\u201cFor patients and health care providers this will provide an option to existing treatments,\u201d Krivi said referring to the competitor to Lantus. Lantus\u00a0generated almost <a href=\"http:\/\/www.businessweek.com\/news\/2014-06-27\/lilly-wins-eu-backing-for-generic-of-sanofis-lantus\">$8 billion in sales<\/a> last year and holds 80 percent of the long-acting insulin market worldwide, according to the <a href=\"http:\/\/articles.chicagotribune.com\/2012-05-29\/news\/sns-rt-sanofi-insulinl5e8gs8rk-20120529_1_long-acting-insulin-levemir-glp-1\">Chicago Tribune<\/a>.<\/p>\n<p style=\"text-align: justify;\">The option of Abasria might also drop the cost of long-acting glargine insulin, <a href=\"http:\/\/www.reuters.com\/article\/2014\/06\/27\/us-europe-medicines-lantus-idUSKBN0F219Q20140627\">according to industry analysts<\/a> who say that, \u201cthe new copycat version (is expected) to be priced significantly lower than Lantus, in order to attract patients and healthcare providers.\u201d<\/p>\n<p style=\"text-align: justify;\">If finally approved Abasria won\u2019t be the only new kid on the increasingly crowded market for long-acting insulin in the EU. In March 2013 Danish drug maker Novo Nordisk launched <a href=\"http:\/\/www.novonordisk.com\/science\/pipeline\/rd_pipeline.asp?showid=1\">Tresiba<\/a> in Europe. Novo said clinical trials results indicated Tresiba worked for more than 42 hours per dose, compared to up to 24 hours per dose for Lantus. Additionally, Novo\u2019s trials showed Tresiba caused fewer hypoglycemic episodes than Lantus.<\/p>\n<p style=\"text-align: justify;\">Tresiba suffered a major setback, however, when the <a href=\"http:\/\/www.reuters.com\/article\/2014\/03\/20\/novo-nordisk-tresiba-idUSL6N0MH4GK20140320\">FDA delayed approval of the insulin for the U.S. market<\/a> in March 2013 asking Novo to conduct further tests on potential heart risks from the drug. Tresiba is still awaiting final approval in the U.S.<\/p>\n<p style=\"text-align: justify;\">Tresiba is not the only other rival to Lantus. It\u2019s not even the only rival from Novo Nordisk. In 2006 Novo introduced the long-acting insulin, <a href=\"http:\/\/www.levemir.com\/\">Levemir<\/a>. Sales of Levemir, however, failed to capture a significant share of the long-acting insulin market.<\/p>\n<p style=\"text-align: justify;\">So many new long-acting insulin configurations are being developed and launched because the patent on Lantus is set to expire soon. In the United States the Lantus patent expires February 2015 and the drug\u2019s patent expires in Europe in May 2015. \u00a0By then, Sanofi expects the regulatory decision for marketing authorization for Toujeo, an improved version of Lantus. \u00a0Abasria, meanwhile, might be delayed from reaching the market until more than a year from now because of <a href=\"http:\/\/www.reuters.com\/article\/2014\/01\/31\/us-sanofi-lilly-insulin-idUSBREA0T23620140131\">litigation brought by Sanofi against and Lilly\/BI<\/a> alleging patent infringements.<\/p>\n<p style=\"text-align: justify;\">Other insulin configurations will likely emerge in the coming years as well, since the market for such drugs will grow at an expected <a href=\"http:\/\/www.grandviewresearch.com\/industry-analysis\/insulin-market\">rate of 12.4% for the next six years<\/a>.<\/p>\n<p style=\"text-align: justify;\">Fueling this growth is a predicted increase globally in the number of people with both type 1 and type 2 diabetes and an increase in the number of type 2 diabetics using insulin. According to <a href=\"http:\/\/www.grandviewresearch.com\/industry-analysis\/insulin-market\">Grand View Research<\/a>, the number of people with diabetes in the world was 366 million three years ago and will grow to an estimated 552 million people in 2030.<\/p>\n<p style=\"text-align: justify;\">\u201cIt is estimated that worldwide, by year 2030, one in ten people will suffer from diabetes, giving rise to a huge demand for insulin,\u201d according to drug industry newsletter <a href=\"http:\/\/www.thepharmaletter.com\/article\/global-insulin-market-expected-to-reach-32-35-million-in-2018-with-china-accounting-for-10-2\">The Pharma Letter<\/a>. \u201cChina, being the most populous nation in the world, accounts for the largest share of the global diabetic population and eventually turns out as the most lucrative market for insulin manufacturers.\u201d<\/p>\n<p style=\"text-align: justify;\">If trends continue, many of those new insulin users might be type 2 diabetics, according to a June 2014 report from the American Medical Association published in <a href=\"http:\/\/www.sciencedaily.com\/releases\/2014\/06\/140610205101.htm\">Science Daily<\/a>. \u201c\u2026 use of insulin among patients with type 2 diabetes increased from 10 percent in 2000 to 15 percent in 2010,\u201d the report said, \u201cand out-of-pocket expenditures per prescription increased from a median of $19 to $36.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"<p>New long-acting insulin configurations are being developed and launched because the patent on Lantus is set to expire soon. In the United States the Lantus patent expires February 2015 and the drug\u2019s patent expires in Europe in May 2015.  <\/p>\n","protected":false},"author":4,"featured_media":42050,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1441],"tags":[143],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.9 (Yoast SEO v22.9) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>The Insulin Games: A Race to Dominate the Growing Market<\/title>\n<meta name=\"description\" content=\"According to Lilly\/BI, Abasria is an \u201cinsulin glargine product, for the treatment of type 1 and type 2 diabetes\u201d and is the \u201cfirst biosimilar insulin recommended for approval in the European Union.\u201d\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/asweetlife.org\/?p=36325\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Alex O\u2019Meara\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/asweetlife.org\/?p=36325\",\"url\":\"https:\/\/asweetlife.org\/?p=36325\",\"name\":\"The Insulin Games: A Race to Dominate the Growing Market\",\"isPartOf\":{\"@id\":\"https:\/\/asweetlife.org\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/asweetlife.org\/?p=36325#primaryimage\"},\"image\":{\"@id\":\"https:\/\/asweetlife.org\/?p=36325#primaryimage\"},\"thumbnailUrl\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/07\/iStock_InsulinPens.jpg\",\"datePublished\":\"2014-07-08T13:05:33+00:00\",\"dateModified\":\"2016-01-11T08:48:18+00:00\",\"author\":{\"@id\":\"https:\/\/asweetlife.org\/#\/schema\/person\/39a63c7215ee072a94bbc4a681de116d\"},\"description\":\"According to Lilly\/BI, Abasria is an \u201cinsulin glargine product, for the treatment of type 1 and type 2 diabetes\u201d and is the \u201cfirst biosimilar insulin recommended for approval in the European Union.\u201d\",\"breadcrumb\":{\"@id\":\"https:\/\/asweetlife.org\/?p=36325#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/asweetlife.org\/?p=36325\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/asweetlife.org\/?p=36325#primaryimage\",\"url\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/07\/iStock_InsulinPens.jpg\",\"contentUrl\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/07\/iStock_InsulinPens.jpg\",\"width\":850,\"height\":565,\"caption\":\"Insulin Pricing Crisis\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/asweetlife.org\/?p=36325#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/asweetlife.org\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"The Insulin Games: A Race to Dominate the Growing Market\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/asweetlife.org\/#website\",\"url\":\"https:\/\/asweetlife.org\/\",\"name\":\"ASweetLife\",\"description\":\"The Diabetes Magazine\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/asweetlife.org\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/asweetlife.org\/#\/schema\/person\/39a63c7215ee072a94bbc4a681de116d\",\"name\":\"Alex O\u2019Meara\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/asweetlife.org\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/d46cda412d65fd79447ff39275a4856e?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/d46cda412d65fd79447ff39275a4856e?s=96&d=mm&r=g\",\"caption\":\"Alex O\u2019Meara\"},\"description\":\"Alex was diagnosed with type 1 diabetes 36 years ago. 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