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European Commission grants marketing authorization for Ranivisio▼®* (ranibizumab), a biosimilar to Lucentis®**, for age-related macular degeneration (AMD) the most common cause of blindness in developed countries

August 29, 2022

Teva Pharmaceuticals to commercialize the product in Europe

  • Age related macular degeneration (AMD) affects around 67 million people in Europe and is a leading cause of blindness for working age adults with uncontrolled diabetes1 and the most common cause of blindness in developed countries2.

  • Ranivisio (ranibizumab) will be the first ophthalmology biosimilar of Lucentis to be commercialized in Europe and is approved for treatment for all five Lucentis indications in adults.

  • Teva entered into a strategic partnership with Bioeq AG for the exclusive commercialization of ranibizumab and intends to launch the product throughout Europe following its July ’22 launch in the United Kingdom under the tradename ONGAVIA▼®.

TEL AVIV, Israel--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. announces that the European Commission (EC) has granted a Marketing Authorization for Ranivisio (ranibizumab), a biosimilar of the ophthalmology treatment Lucentis across all five indications in adults for which Lucentisis authorized.

Richard Daniell, Executive Vice President, European Commercial, Teva Pharmaceuticals commented: “With millions of people in Europe afflicted by this serious age-related eye condition this important milestone allows us, together with Bioeq, to bring ranibizumab to ophthalmologists and patients throughout Europe. The product is a welcome addition to Teva’s growing biosimilars portfolio, and delivers on our mission to improve patient access to critical therapies while delivering vital savings to healthcare systems.”

Ranivisiois licensed in adults totreat age-related macular degeneration (AMD) and four other ophthalmology indications: visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment resulting from diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), and choroidal neovascularisation (CNV).

Around 67 million people in Europe are affected by AMD. It is a leading cause of blindness for working age adults with uncontrolled diabetes3, and the most common cause of blindness in developed countries2. It is estimated that up to 77 million Europeans will be affected with AMD by 20504.

AMD is caused by excessive growth of blood vessels in the retina that leads to visual impairment and can even cause blindness. Ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of these blood vessels in the retina5.

In the COLUMBUS-AMD study, a randomized, double-masked, parallel group, multi-centre phase III study6, ranibizumab was shown to be highly similar to its reference medicine in terms of clinical efficacy and ocular and systemic safety in the treatment of AMD and its other ophthalmology indications.

* Ranivisio is a registered trademark of Bioeq AG, licensed by Teva
** Lucentis® is a registered trademark of Genentech Inc.

About Teva: Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic, biosimilar and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com

About Bioeq: Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and Formycon AG. Bioeq develops, licenses and commercializes biosimilars. www.bioeq.ch

About Formycon: Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval.

About Polpharma Biologics: Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas

References:

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1 Written by Editor. January 15, 2019 · Last reviewed January 7, 2022. Available at: https://www.diabetes.co.uk/diabetes-complications/diabetes-and-blindness.html

2 Colin S. Tan, SriniVas R. Sadda. 2017, Pages 89-116, Chapter 7. Neovascular (Wet) Age-Related Macular Degeneration. Academic Press, ISBN 9780128053133. Available at: https://doi.org/10.1016/B978-0-12-805313-3.00007-7

3 Written by Editor. January 15, 2019 · Last reviewed January 7, 2022. Available at: https://www.diabetes.co.uk/diabetes-complications/diabetes-and-blindness.html

4 Li JQ, Welchowski T, Schmid M, et alPrevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis British Journal of Ophthalmology 2020;104:1077-1084 available at: https://bjo.bmj.com/content/104/8/1077

5 John Lowe et al., Experimental Eye Research 85 (2007) 425e430, Ranibizumab inhibits multiple forms of biologically active vascular endothelial growth factor in vitro and in vivo Available at: https://www.sciencedirect.com/science/article/abs/pii/S0014483507001534

6 Frank G Holz , Piotr Oleksy, Federico Ricci, Peter K Kaiser , Joachim Kiefer, Steffen Schmitz-Valckenberg, COLUMBUS-AMD Study Group - Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration, JAMA Ophthalmol. 2021 Jan 1;139(1):68-76. doi: 10.1001/jamaophthalmol.2020.5053 Available at: https://pubmed.ncbi.nlm.nih.gov/33957183/

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to the development and commercial success of our biosimilar portfolio; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our specialty products, including AUSTEDO®, AJOVY® and COPAXONE®; our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including uncertainty regarding the COVID-19 pandemic and the governmental and societal responses thereto; our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2022 and in our Annual Report on Form 10-K for the year ended December 31, 2021, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

Fiona Cohen fiona.cohen@tevaeu.com

Source: Teva Pharmaceutical Industries Limited

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