{"id":787173,"date":"2023-09-29T16:34:37","date_gmt":"2023-09-29T20:34:37","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-approves-biogens-tofidence-tocilizumab-bavi-a-biosimilar-referencing-actemra\/"},"modified":"2023-09-29T16:34:37","modified_gmt":"2023-09-29T20:34:37","slug":"fda-approves-biogens-tofidence-tocilizumab-bavi-a-biosimilar-referencing-actemra","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-approves-biogens-tofidence-tocilizumab-bavi-a-biosimilar-referencing-actemra\/","title":{"rendered":"FDA Approves Biogen\u2019s TOFIDENCE\u2122 (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA\u00ae"},"content":{"rendered":"<div class=\"mw_release\">\n<ul>\n<li style=\"text-align:left\">TOFIDENCE (BIIB800) becomes the first tocilizumab biosimilar to gain FDA approval in the United States<\/li>\n<li>FDA approval is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE to the reference product ACTEMRA<\/li>\n<\/ul>\n<p>CAMBRIDGE, Mass., Sept.  29, 2023  (GLOBE NEWSWIRE) &#8212; <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=PwTUR4p4iOsBJmicUAJfr4aHlSgHK4M_-36x03bCNC06R-WSE3XqeBB1JWqHKlB0VB0znrbhNz2kWbmtLns7kw==\" rel=\"nofollow noopener\" target=\"_blank\">Biogen Inc.<\/a>\u00a0(Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA. The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.<\/p>\n<p>TOFIDENCE is the first tocilizumab biosimilar approved in the United States. Biosimilars are biologic products that have been demonstrated to have equivalent efficacy and comparable safety as the approved reference product, with the advantage that they may offer cost savings and promote expanded and sustainable access to therapies. Spending on therapies for autoimmune diseases has consistently increased by 10%\u201325% each year over the past decade<sup>1<\/sup>. Since biosimilar entry in the US, medicines with biosimilar competition have experienced greater patient adoption equaling more than 150 million days of patient therapy<sup>1<\/sup>.<\/p>\n<p>\u201cThe approval of TOFIDENCE in the U.S. marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,\u201d said Ian Henshaw, Global Head of Biosimilars at Biogen. \u201cWith the increasing numbers of approved biosimilars, we expect increased savings and sustainability for healthcare systems and an increase in physician choice and patient access to biologics.\u201d<\/p>\n<p>Biogen and Bio-Thera entered into a commercialization and license agreement for TOFIDENCE (BAT1806\/BIIB800) in April 2021. Developed by Bio-Thera, TOFIDENCE will be commercialized by Biogen in the United States. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China (including Hong Kong, Macau and Taiwan). Biogen is currently evaluating the potential launch timeline for TOFIDENCE in the U.S.<\/p>\n<p>The FDA approval of TOFIDENCE was based on a comprehensive analytical, non-clinical and clinical data package submitted by Biogen to the FDA in Sept 2022. Extensive analytical characterization of the structural, physicochemical, and biological properties of TOFIDENCE was conducted and supports biosimilarity with the reference product. Additionally, a randomized double-blind,\u00a0single-dose,\u00a0three-arm,\u00a0parallel\u00a0phase I study compared the pharmacokinetics, safety and immunogenicity of TOFIDENCE with both the US and EU reference tocilizumab in healthy volunteers, while a randomized, double-blind, multi-dose, three-arm parallel phase III study compared TOFIDENCE with tocilizumab to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with rheumatoid arthritis inadequately controlled by methotrexate. The totality of evidence demonstrated TOFIDENCE is a biosimilar of the reference biologic.<\/p>\n<p>\n        <strong>About TOFIDENCE (tocilizumab)<\/strong><br \/>\n        <br \/>TOFIDENCE (tocilizumab), is a treatment developed as a biosimilar to the reference product ACTEMRA. TOFIDENCE is indicated for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.\u00a0\u00a0<\/p>\n<p>\n        <strong>Indications<\/strong><br \/>\n        <br \/>\n        <strong>Rheumatoid Arthritis (RA) <\/strong><br \/>\n        <br \/>Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).<\/p>\n<p>\n        <strong>Polyarticular Juvenile Idiopathic Arthritis (PJIA) <\/strong><br \/>\n        <br \/>Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.<\/p>\n<p>\n        <strong>Systemic Juvenile Idiopathic Arthritis (SJIA) <\/strong><br \/>\n        <br \/>Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.<\/p>\n<p>\n        <strong>IMPORTANT SAFETY INFORMATION<\/strong><br \/>\n        <br \/>\n        <strong>The U.S. prescribing information for TOFIDENCE includes a boxed WARNING for RISK OF SERIOUS INFECTIONS: <\/strong><br \/>\n        <strong>Patients treated with <\/strong><br \/>\n        <strong>tocilizumab products including TOFIDENCE<\/strong><br \/>\n        <strong> are at increased risk for developing serious infections that may lead to<\/strong><br \/>\n        <strong>hospitalization or death<em>. <\/em>Most patients who<\/strong><br \/>\n        <strong>developed these infections were taking concomitant immunosuppressants such as methotrexate or<\/strong><br \/>\n        <strong>corticosteroids.<\/strong>\n      <\/p>\n<p>\n        <strong>If a serious infection develops, interrupt <\/strong><br \/>\n        <strong>TOFIDENCE<\/strong><br \/>\n        <strong> until the infection is controlled.<\/strong>\n      <\/p>\n<p>\n        <strong>Reported infections include:<\/strong>\n      <\/p>\n<ul>\n<li>\n          <strong>Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should<\/strong><br \/>\n          <strong>be tested for latent tuberculosis before <\/strong><br \/>\n          <strong>TOFIDENCE<\/strong><br \/>\n          <strong> use and during therapy. Treatment for latent<\/strong><br \/>\n          <strong>infection should be initiated prior to <\/strong><br \/>\n          <strong>TOFIDENCE<\/strong><br \/>\n          <strong> use.<\/strong>\n        <\/li>\n<li>\n          <strong>Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with<\/strong><br \/>\n          <strong>invasive fungal infections may present with disseminated, rather than localized, disease.<\/strong>\n        <\/li>\n<li>\n          <strong>Bacterial, viral and other infections due to opportunistic pathogens.<\/strong>\n        <\/li>\n<\/ul>\n<p>\n        <strong>The risks and benefits of treatment with <\/strong><br \/>\n        <strong>TOFIDENCE<\/strong><br \/>\n        <strong> should be carefully considered prior to initiating<\/strong><br \/>\n        <strong>therapy in patients with chronic or recurrent infection.<\/strong>\n      <\/p>\n<p>\n        <strong>Patients should be closely monitored for the development of signs and symptoms of infection during and after<\/strong><br \/>\n        <strong>treatment with <\/strong><br \/>\n        <strong>TOFIDENCE<\/strong><br \/>\n        <strong>, including the possible development of tuberculosis in patients who tested<\/strong><br \/>\n        <strong>negative for latent tuberculosis infection prior to initiating therapy<em>.<\/em><\/strong>\n      <\/p>\n<p>\n        <strong>Contraindications<\/strong><br \/>\n        <br \/>TOFIDENCE is contraindicated in patients with known hypersensitivity to tocilizumab products.<\/p>\n<p>\n        <strong>Warnings and Precautions<\/strong><br \/>\n        <br \/>Serious Infections &#8211; do not administer TOFIDENCE during an active infection, including localized infections. If a serious infection develops, interrupt TOFIDENCE until the infection is controlled.<\/p>\n<p>Gastrointestinal (GI) perforation &#8211; use with caution in patients who may be at increased risk.<\/p>\n<p>Hepatotoxicity &#8211; Monitor patients for signs and symptoms of hepatic injury. Modify or discontinue TOFIDENCE if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.<\/p>\n<p>Laboratory monitoring &#8211; recommended due to potential consequences of treatment-related changes in neutrophils, platelets, lipids, and liver function tests.<\/p>\n<p>Hypersensitivity reactions, including anaphylaxis and death have occurred.<\/p>\n<p>Live vaccines &#8211; Avoid use with TOFIDENCE.<\/p>\n<p>\n        <strong>Adverse Reactions<\/strong><br \/>\n        <br \/>Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT.<\/p>\n<p>For additional Important Safety Information on TOFIDENCE (tocilizumab-bavi), see <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=C8NQQhBfWmyIWqF835Br0d0WgQT3ZlsMR3yfVURR54sgJXiS_RAJM0OKCj0x1jCp35W7yFvKmvkwT8Ur0XPi267KDIXBXg_oeT8pgWxC5NvvUwtSK7FIYuqak4OXwqwEWvnl2uPuHFMR1F2a9nkexg==\" rel=\"nofollow noopener\" target=\"_blank\">full Prescribing Information<\/a>.<\/p>\n<p>\n        <strong>About Biogen<\/strong><br \/>\n        <br \/>Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer\u2019s disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.<\/p>\n<p>We routinely post information that may be important to investors on our website at\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=6H28LOh-zYIDgVJYHa5LfKxUbrNhTI9RYLO9lYbumbOB0glGKEgb8lgEQQF8zT2wSOMaVW93hFV_qRt8VhmDgg==\" rel=\"nofollow noopener\" target=\"_blank\">www.biogen.com<\/a>.\u00a0Follow us on social media\u00a0&#8211;\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=ERKl4JEtcbs9qOJyjxfr3ORuwHSAi7D1-YokaQ7vz0e0EY395UDQ2mrj4f9ivASM3u1I6kjahNhbhXiLXrurbQ==\" rel=\"nofollow noopener\" target=\"_blank\">X<\/a>,\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=ztNibZkiZAoUHaaERxVgz_zY1KA-FfRdvbXTu7EqEQbzsFeqaEBSSm1bgWwggSy5TiOqbzhQ-3tuT_Ig4XLOjAafPvQJwEsE49Y6P6zr5dw=\" rel=\"nofollow noopener\" target=\"_blank\">LinkedIn<\/a>,\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=Hotz_CPNiTx0gmfr4bSw1jGK-plBWKHfPpffkXEaeWXeCK1bOfW_9C1iyxa7PA-ouuxM9dH5P_u3GNtBRrSjUwWFtft4Kx5Zyoxi1Nfou6I=\" rel=\"nofollow noopener\" target=\"_blank\">Facebook<\/a>,\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=RNWg8q5mJskbxMkLyL-v6AYoeHWBej0KorxUL697kKXAmTKPEUY1am8cYW19IORkEBbx75YehRg-VqwY7B5gIw==\" rel=\"nofollow noopener\" target=\"_blank\">YouTube<\/a>.<\/p>\n<p>\n        <strong>Biogen Safe Harbor\u00a0<\/strong><br \/>\n        <br \/>This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to the potential benefits, safety and efficacy of TOFIDENCE; potential benefits of our collaboration with Bio-Thera; risks and uncertainties associated with drug development and commercialization; the potential of Biogen\u2019s commercial business and pipeline programs; Biogen\u2019s strategy and plans; and potential cost healthcare savings related to biosimilars. These forward-looking statements may be accompanied by words such as \u201caim,\u201d \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cforecast,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpossible,\u201d \u201cwill,\u201d \u201cwould\u201d and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.<\/p>\n<p>These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, risks that risks of unexpected costs or delays or other unexpected hurdles; uncertainty of success in the commercialization of TOFIDENCE, which may be impacted by, among other things, unexpected concerns that may arise from additional data or analysis, the occurrence of adverse safety events, failure to obtain regulatory approvals in certain jurisdictions, failure to protect and enforce data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; risks of legal actions, regulatory scrutiny or other challenges to biosimilars; the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen\u2019s business, results of operations and financial condition; the risks of doing business internationally, including currency exchange rate fluctuations; product liability claims; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen\u2019s expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in Biogen\u2019s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen\u2019s current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements.<\/p>\n<p>\n        <em>References:<\/em><br \/>\n        \n      <\/p>\n<ol style=\"list-style-type:decimal\">\n<li style=\"margin-bottom:10pt\">Association for Accessible Medicines. The U.S. Generic &amp; Biosimilars Medicines Savings Report, September 2022. https:\/\/accessiblemeds.org\/sites\/default\/files\/2022-09\/AAM-2022-Generic-Biosimilar-Medicines-Savings-Report.pdf Accessed August 2023.<\/li>\n<\/ol>\n<table style=\"border-collapse: collapse;width:100%;border-collapse:collapse\">\n<tr>\n<td style=\"max-width:50%;width:50%;min-width:50%;vertical-align: top\">MEDIA CONTACT:<br \/><strong>Biogen<\/strong><br \/>Jack Cox<br \/>+ 1 781 464 3260<br \/><a href=\"mailto:public.affairs@biogen.com\" rel=\"nofollow noopener\" target=\"_blank\">public.affairs@biogen.com<\/a><\/td>\n<td style=\"max-width:50%;width:50%;min-width:50%;vertical-align: top\">INVESTOR CONTACT:<br \/><strong>Biogen<\/strong><br \/>Chuck Triano<br \/>+1 781 464 2442<br \/><a href=\"mailto:IR@biogen.com\" rel=\"nofollow noopener\" target=\"_blank\">IR@biogen.com<\/a><\/td>\n<\/tr>\n<tr>\n<td style=\"max-width:50%;width:50%;min-width:50%;vertical-align: top\">\u00a0<\/td>\n<td style=\"max-width:50%;width:50%;min-width:50%;vertical-align: top\">\u00a0<\/td>\n<\/tr>\n<\/table>\n<p>      <img decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODkzMTIyOCM1ODM5OTI3IzIwMDk2ODQ=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" src=\"https:\/\/ml.globenewswire.com\/media\/NGJjZTdmM2QtMzFhMi00YjAzLWJhMTQtZjZmYjU4ZjZhZjAyLTEwMjEyNTc=\/tiny\/Biogen-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>TOFIDENCE (BIIB800) becomes the first tocilizumab biosimilar to gain FDA approval in the United States FDA approval is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE to the reference product ACTEMRA CAMBRIDGE, Mass., Sept. 29, 2023 (GLOBE NEWSWIRE) &#8212; Biogen Inc.\u00a0(Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA. The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. TOFIDENCE is the first tocilizumab biosimilar approved in the United States. Biosimilars are biologic products that have been demonstrated to have equivalent efficacy and comparable safety as the &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/fda-approves-biogens-tofidence-tocilizumab-bavi-a-biosimilar-referencing-actemra\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Approves Biogen\u2019s TOFIDENCE\u2122 (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA\u00ae&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-787173","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA Approves Biogen\u2019s TOFIDENCE\u2122 (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA\u00ae - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/fda-approves-biogens-tofidence-tocilizumab-bavi-a-biosimilar-referencing-actemra\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Approves Biogen\u2019s TOFIDENCE\u2122 (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA\u00ae - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"TOFIDENCE (BIIB800) becomes the first tocilizumab biosimilar to gain FDA approval in the United States FDA approval is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE to the reference product ACTEMRA CAMBRIDGE, Mass., Sept. 29, 2023 (GLOBE NEWSWIRE) &#8212; Biogen Inc.\u00a0(Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA. The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. TOFIDENCE is the first tocilizumab biosimilar approved in the United States. Biosimilars are biologic products that have been demonstrated to have equivalent efficacy and comparable safety as the &hellip; Continue reading &quot;FDA Approves Biogen\u2019s TOFIDENCE\u2122 (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA\u00ae&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/fda-approves-biogens-tofidence-tocilizumab-bavi-a-biosimilar-referencing-actemra\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2023-09-29T20:34:37+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODkzMTIyOCM1ODM5OTI3IzIwMDk2ODQ=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/fda-approves-biogens-tofidence-tocilizumab-bavi-a-biosimilar-referencing-actemra\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/fda-approves-biogens-tofidence-tocilizumab-bavi-a-biosimilar-referencing-actemra\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"FDA Approves Biogen\u2019s TOFIDENCE\u2122 (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA\u00ae\",\"datePublished\":\"2023-09-29T20:34:37+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/fda-approves-biogens-tofidence-tocilizumab-bavi-a-biosimilar-referencing-actemra\\\/\"},\"wordCount\":1464,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/fda-approves-biogens-tofidence-tocilizumab-bavi-a-biosimilar-referencing-actemra\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODkzMTIyOCM1ODM5OTI3IzIwMDk2ODQ=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/fda-approves-biogens-tofidence-tocilizumab-bavi-a-biosimilar-referencing-actemra\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/fda-approves-biogens-tofidence-tocilizumab-bavi-a-biosimilar-referencing-actemra\\\/\",\"name\":\"FDA Approves Biogen\u2019s TOFIDENCE\u2122 (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA\u00ae - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-approves-biogens-tofidence-tocilizumab-bavi-a-biosimilar-referencing-actemra\/","og_locale":"en_US","og_type":"article","og_title":"FDA Approves Biogen\u2019s TOFIDENCE\u2122 (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA\u00ae - Market Newsdesk","og_description":"TOFIDENCE (BIIB800) becomes the first tocilizumab biosimilar to gain FDA approval in the United States FDA approval is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE to the reference product ACTEMRA CAMBRIDGE, Mass., Sept. 29, 2023 (GLOBE NEWSWIRE) &#8212; Biogen Inc.\u00a0(Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA. The TOFIDENCE intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. TOFIDENCE is the first tocilizumab biosimilar approved in the United States. 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