TEVA UK Grants First European License for Ongavia
May 17, 2022 16:55:50 GMT
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Post by highskier on May 17, 2022 16:55:50 GMT
United Kingdom first to grant licence for Teva’s ophthalmology biosimilar Ongavia (ranibizumab)
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
AMSTERDAM, May 17, 2022--(BUSINESS WIRE)--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."
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
AMSTERDAM, May 17, 2022--(BUSINESS WIRE)--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.
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.