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European Commission approves pharma trio’s Ranivisio

Therapy is a biosimilar of Lucentis which treats several serious retinal diseases across the European Union.

The European Commission (EC) has granted marketing authorisation to Polpharma Biologics, Formycon and Bioeq jointly developed treatment Ranivisio – also known as ranibizumab – a biosimilar of Lucentis. The original therapy is already a treatment for several serious retinal diseases across the EU.

EC approval follows a positive opinion issued in June 2022 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to all 27 EU member states plus Iceland, Norway and Liechtenstein.

Ranivisio is indicated for the treatment of neovascular age-related macular degeneration, the treatment of visual impairment due to diabetic macular oedema and choroidal neovascularisation (CNV). It also includes the treatment of proliferative diabetic retinopathy and visual impairment due to macular oedema secondary to retinal vein occlusion.

Ranivisio was developed by Bioeq in a joint venture between Polpharma Biologics and Formycon. Furthermore, in mid-2021 Teva entered into a strategic partnership for the exclusive commercialisation of Ranivisio in Europe and selected other countries.

Commercial launches across Europe are planned over the coming year, while the treatment is already available in the UK under the trade name Ongavia, following its approval by the Medicines and Healthcare products Regulatory Agency in May 2022.

“The production of biosimilars is a process with high levels of scientific rigour and the approval of Ranivisio is the culmination of years of dedication by Polpharma Biologics, and our partners, to successfully engineer this medical advancement for those with severe retinal impairments,” reflected Michael Soldan, chief executive officer at Polpharma Biologics. “We look forward to working with our strategic partners to rapidly get this very important treatment to the people across Europe who need it most.”

“Due to the demographic development, more and more people in Europe are affected by age-related macular degeneration and other severe retinal diseases. This is very often accompanied by significant impairment of quality of life. We are therefore particularly pleased Ranivisio can contribute to the treatment options of ophthalmologists and best possible care for these patients,” concluded Dr Stefan Glombitza, chief executive officer at Formycon.