United Kingdom first to grant licence for Teva’s ophthalmology biosimilar Ongavia (ranibizumab) ▼
Teva Pharmaceutical Industries Ltd welcomes the UK Medicines & Healthcare Regulatory Agency (MHRA) decision to grant a licence for Ongavia®, a biosimilar to Lucentis® (ranibizumab ), an eye injection. The United Kingdom is the first country in Europe to authorize commercialization of Ongavia®for the treatment of neovascular (wet) age-related macular degeneration (“AMD”). Ongavia® is also licenced for: the treatment of visual impairment due to diabetic macular oedema (DME); the treatment of proliferative diabetic retinopathy (PDR); the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO); and the treatment of visual impairment due to choroidal neovascularisation (CNV).
Ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina2. Teva's biosimilar ranibizumab is highly similar to its reference medicine in terms of clinical efficacy, ocular and systemic safety in the treatment of patients with AMD and its other indications, as shown in the COLUMBUS-AMD study (a randomized, double-masked, parallel group, multi-centre phase III study3).
Welcoming the news, Richard Daniell, Executive Vice President, Teva Europe Commercial, said: “Teva is pleased to bring the first biosimilar for Lucentis® in ophthalmology to clinicians and patients in the UK. Our mission is to improve access to advanced treatments at attainable prices and we are establishing a role for biosimilars. We believe that unlocking value in biologics is the new frontier in medicine and lowering system costs around the globe is the key to broadening patient access. We are committed to high quality products and services to support the ophthalmology community.”
Teva entered into a strategic partnership for the exclusive commercialisation of ranibizumab with Bioeq AG. Teva hopes to commercialise the ranibizumab biosimilar across Europe.
AMD is the most common cause of blindness in developed countries and it is estimated that up to 77 million Europeans will be affected by 20504. The consequences carry a significant global burden for healthcare systems and society. With the incidence of wet AMD increasing, it is expected that a considerable amount of healthcare resources and careful planning will be needed for decades to come.4
* Lucentis® is a registered trademark of Genentech Inc.
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
Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and the Formycon Group. Bioeq develops, licenses and commercializes biosimilars. www.bioeq.ch
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 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
3Frank 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/
4 Li JQ, Welchowski T, Schmid M, et al Prevalence 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
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, approval and commercialization of our ophthalmology biosimilar Ongavia® (ranibizumab); the development, approval and commercialization of our other products included in our biosimilars pipeline; the 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 first 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.
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