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▼®.
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 Lucentis is
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.”
Ranivisio is licensed in adults to treat 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:
___________________________
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
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Fiona Cohen fiona.cohen@tevaeu.com
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