Teva Receives Approval for First Ophthalmology Biosimilar in Europe

Earlier this week, Teva Pharmaceutical Industries Ltd. (Teva) announced that the UK Medicines & Healthcare Regulatory Agency (MHRA) approved ONGAVIA, a ranibizumab biosimilar referencing Genentech’s LUCENTIS.  Ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.

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 licensed 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 neovascularization (CNV).

Teva had entered into a strategic partnership with Bioeq AG, a Swiss biopharmaceutical joint venture, for the exclusive commercialization of ONGAVIA.  According to the press release, Teva hopes to commercialize ONGAVIA across Europe.

About Teva Pharmaceutical

Teva Pharmaceutical Industries Ltd is a global leader in generics and biopharmaceutical medicines and has been developing and producing medicines to improve people’s lives for more than a century.