{"id":19692,"date":"2019-05-29T09:55:16","date_gmt":"2019-05-29T09:55:16","guid":{"rendered":"https:\/\/strammer.com\/?p=19692"},"modified":"2019-05-29T09:55:16","modified_gmt":"2019-05-29T09:55:16","slug":"medical-generic-and-biosimilar-products-launches-in-eu","status":"publish","type":"post","link":"https:\/\/strammer.com\/en\/medical-generic-and-biosimilar-products-launches-in-eu\/","title":{"rendered":"Medical Generic and Biosimilar Products launches in EU"},"content":{"rendered":"
<\/div><\/div>

Generics and Biosimilar Products to be Launched in Europe<\/span><\/h1>
<\/div><\/div><\/div>

EU launches medical generic and biosimilar products<\/span><\/p>\n

In the pharmaceutical field,\u00a0generics\u00a0and biosimilars<\/strong> have\u00a0proven\u00a0to\u00a0be\u00a0an essential way to\u00a0combat\u00a0the rising costs of\u00a0medicine<\/strong>\u00a0all the\u00a0while\u00a0maintaining\u00a0the\u00a0offer\u00a0of high-quality products that\u00a0satisfy\u00a0both\u00a0patients\u00a0and buyers alike.\u00a0Hence, such\u00a0products\u00a0keep in line the\u00a0need\u00a0to\u00a0have\u00a0medicine\u00a0and healthcare affordable and accessible<\/strong> to all. When the\u00a0announcement\u00a0was\u00a0made\u00a0in April 2019 that an easier production of\u00a0generics\u00a0and biosimilars in the European Union will\u00a0begin\u00a0in mid-2022, many parties involved within the\u00a0healthcare\u00a0and pharmaceutical industry were enamoured.<\/p>\n

Simply\u00a0put, a\u00a0generic<\/strong>\u00a0is\u00a0defined\u00a0as a medicinal\u00a0product\u00a0that\u00a0shares\u00a0similar qualities or\u00a0compositions<\/strong>\u00a0as the reference\u00a0product\u00a0or its original.\u00a0Likewise, a biosimilar<\/strong> share the same characteristics, biological composition,\u00a0safety\u00a0and efficacy tributes<\/b> to the reference medicinal\u00a0product.\u00a0While conventional generic medicines\u00a0have\u00a0more\u00a0chemical components, biosimilars are\u00a0composed\u00a0of\u00a0more\u00a0complex compounds like\u00a0proteins,\u00a0sugars\u00a0or nucleic acids.\u00a0However, both\u00a0products\u00a0are\u00a0granted\u00a0regulatory approval and measures <\/strong>in defined daily\u00a0dosages\u00a0measured by the\u00a0World Health Organisation\u00a0(WHO).<\/p>\n

The\u00a0generics\u00a0and biosimilars industry has been doing well in other\u00a0countries.\u00a0For example, in the US, these medicinal products in the pharmaceutical field have been quite practical for patients and buyers as the prices are relatively lower<\/strong> than the originals.\u00a0In\u00a0fact,\u00a0according\u00a0to the 2017 Generic Drug Access and Savings Report, medical companies who have\u00a0bought\u00a0these generic and biosimilar products have\u00a0earned\u00a0savings\u00a0of a\u00a0total\u00a0of $44 billion.\u00a0In\u00a0total, the U.S. healthcare system has\u00a0saved\u00a0$1.67 trillion.<\/p>\n

With a strict EU patent law in force, it was challenging originally to have generics and biosimilars to be circulated in and around the EU.\u00a0Such\u00a0drawbacks\u00a0meant\u00a0that certain drugs were\u00a0limited, inaccessible or quite expensive<\/strong> for\u00a0purchase.\u00a0What EU members and delegates wish to do presently is to help eliminate these barriers.\u00a0Henceforth, the\u00a0recent\u00a0patent\u00a0law<\/strong>\u00a0that was\u00a0passed\u00a0in the European Parliament in April this\u00a0year\u00a0hopes\u00a0to\u00a0relax\u00a0the\u00a0existing\u00a0laws\u00a0and regulations under medicinal licencing and\u00a0protection law<\/strong>.<\/p>\n

The\u00a0new\u00a0EU regulation, which will take effect on July 2022, will\u00a0allow\u00a0Europe generics manufacturers to\u00a0start\u00a0the\u00a0production\u00a0of these\u00a0products\u00a0as well as exportation <\/strong>to third countries when needed.\u00a0Furthermore, in some\u00a0cases,\u00a0manufacturers\u00a0will\u00a0be able to\u00a0make\u00a0their drug copies for\u00a0market\u00a0use within Europe even\u00a0months\u00a0before the\u00a0original\u00a0patent production expires.\u00a0In addition, the\u00a0law\u00a0will further allow pharmaceutical companies exclusive access into the\u00a0EU\u00a0market<\/strong>\u00a0for up to 5\u00a0years<\/strong>\u00a0after the 20-year patent protection test phase and\u00a0pre-market\u00a0trial period for their\u00a0original\u00a0medicines.<\/p>\n

Advancing\u00a0further\u00a0with the\u00a0generics\u00a0and biosimilars industry will do well for the healthcare system in the\u00a0EU.\u00a0Experts\u00a0and\u00a0officials\u00a0are already predicting the\u00a0benefits the\u00a0region\u00a0will\u00a0gain\u00a0when the\u00a0new\u00a0law will be\u00a0enforced.<\/p>\n

EU\u00a0commissioner for Internal Market and Industry\u00a0Elzbieta\u00a0Bienkowska\u00a0mentioned during the\u00a0announcement\u00a0that,<\/p>\n

\n

\u201cWe are\u00a0eliminating\u00a0a\u00a0major\u00a0competitive\u00a0disadvantage for\u00a0EU\u00a0producers, who will soon be able to\u00a0compete\u00a0on the\u00a0highly\u00a0competitive\u00a0world markets on\u00a0equal\u00a0terms.\u00a0\u00bb<\/em><\/p>\n<\/blockquote>\n

It\u00a0was further mentioned that it is expected for the industry to increase in sales across Europe to at least 1 billion euros annually or more, especially with the new export opportunities with neighbouring countries.\u00a0It\u00a0was\u00a0also\u00a0said\u00a0that within approximately 10\u00a0years, there will\u00a0be\u00a0a boost\u00a0in up to 25,000\u00a0jobs\u00a0entering\u00a0the\u00a0EU pharmaceutical\u00a0market.<\/p>\n

References:<\/u><\/span><\/p>\n

    \n
  1. Generics and biosimilars to be launched faster in Europe. HandelsBlatt<\/a><\/span><\/li>\n
  2. Health At A Glance OECD 2017 Report, OECD<\/a><\/span><\/li>\n
  3. Generics and Biosimilars Drive Access and Savings for the U.S. Healthcare System, June 2017, Mylan<\/a><\/span><\/li>\n
  4. Industry touts savings potential of generics and biosimilars, 2018, Biopharmadive<\/a><\/span><\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"","protected":false},"author":7,"featured_media":19699,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","myguten_meta_block_field":"","footnotes":""},"categories":[98],"tags":[],"class_list":["post-19692","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/posts\/19692","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/comments?post=19692"}],"version-history":[{"count":0,"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/posts\/19692\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/media\/19699"}],"wp:attachment":[{"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/media?parent=19692"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/categories?post=19692"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/strammer.com\/en\/wp-json\/wp\/v2\/tags?post=19692"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}