United Kingdom first to grant licence for Teva’s ophthalmology biosimilar Ongavia (ranibizumab)▼
2022年5月17日 - 10:10PM
ビジネスワイヤ(英語)
- MHRA today granted a licence for Ongavia®▼
(ranibizumab), a biosimilar to Lucentis®*, for the treatment of
(wet) age-related macular degeneration (AMD) and several other eye
diseases, such as diabetic macular oedema and proliferative
diabetic retinopathy
- AMD is a leading cause of blindness for working age adults
with uncontrolled diabetes.1
- Ongavia®▼ will be the first ophthalmology
biosimilar commercialised by Teva in Europe
- In recent years, biosimilars have delivered significant
savings to healthcare systems across the UK and other European
markets
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.
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 the Formycon Group. Bioeq develops,
licenses and commercializes biosimilars. www.bioeq.ch
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 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 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
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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
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Fiona Cohen Fiona.cohen@tevaeu.com
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