AMSTERDAM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd welcomes the decision of the UK Medicines and Healthcare Regulatory Agency (MHRA) to license Ongavia®, a biosimilar to Lucentis® (ranibizumab), an eye injection. The United Kingdom is the first country in Europe to authorize the commercialization of Ongavia® for the treatment of neovascular (wet) age-related macular degeneration (“AMD”). ongavia® is also authorized for: the treatment of visual impairment due to diabetic macular edema (DME); the treatment of proliferative diabetic retinopathy (PDR); treatment of visual impairment due to macular edema secondary to retinal vein occlusion (branch OVR or central OVR); and the treatment of visual impairment due to choroidal neovascularization (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 very 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 (study randomized, double-blind, parallel-group, multicenter phase III study3).
Welcoming the news, Richard Daniell, Executive Vice President, Teva Europe Commercial, said, “Teva is delighted to introduce the first Lucentis biosimilar® in ophthalmology to clinicians and patients in the UK. Our mission is to improve access to advanced treatments at affordable prices and we are establishing a role for biosimilars. We believe that unlocking the value of biologics is the new frontier of medicine and that reducing system costs worldwide is the key to expanding patient access. We are committed to providing high quality products and services to support the eye care community. »
Teva has entered into a strategic partnership for the exclusive commercialization of ranibizumab with Bioeq AG. Teva hopes to market 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 weigh heavily on health systems and society. With the increasing incidence of wet AMD, it is expected that a considerable amount of healthcare resources and careful planning will be required 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 of over 3,500 products in nearly every therapeutic area. Approximately 200 million people worldwide 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 that support our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com
Bioeq is a Swiss biopharmaceutical joint venture between Polpharma Biologics Group and Formycon Group. Bioeq develops, licenses and markets biosimilars. www.bioeq.ch
1 Written by the publisher. January 15, 2019 Last revised 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
3 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 Versus 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 Met 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
Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on management’s current beliefs and expectations and are subject to substantial known and unknown risks and uncertainties that could cause our future results. , performance or achievements differ materially from those 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 related to the development, approval and commercialization of our ophthalmic 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 biopharmaceuticals, competition for our specialty products, including AUSTEDO®AJOVY® and COPAXONE®; our ability to achieve expected results from investments in our product portfolio, 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 generally, including uncertainty regarding the COVID-19 pandemic and governmental and societal responses thereto; our ability to successfully perform and maintain operations and efforts related to actions we have taken or may take in response to the COVID-19 pandemic and associated costs; costs and delays resulting from the extensive pharmaceutical regulations we are subject to or delays in government 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 our Annual Report on Form 10-K for the year ended December 31, 2021, including in the section titled “Factors of risk “. Forward-looking statements speak only as of the date they are made, and we undertake 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 place undue reliance on these forward-looking statements.