European Commission Approves Second Lucentis Biosimilar

The European Commission (EC) granted marketing authorization to Teva Pharmaceuticals’ ranibizumab biosimilar (Ranivisio), the second ophthalmology biosimilar and the second biosimilar to reference Lucentis to be approved in the European Union (EU).

The biosimilar was approved for all 5 indications of the reference product: neovascular age-related macular degeneration (AMD), macular edema, diabetic macular edema, proliferative diabetic retinopathy, and choroidal neovascularization.

The approval comes a few months after the biosimilar was approved in the United Kingdom, where it is marketed under the name Ongavia.

AMD results from the excessive growth of blood vessels in the retina, which can lead to impaired vision and blindness. There are about 67 million people in Europe living with AMD, which is the leading cause of blindness in high-income nations. By 2050, AMD is expected to affect 77 million Europeans.

“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,” said Richard Daniell, executive vice president of european commercial at Teva, in a statement.

In June 2022, the European Committee for Medicinal Products for Human Use adopted a positive opinion, recommending that the EC approve the biosimilar.

The approval followed the EU approval of Byooviz, the first ranbizumab and first ophthalmology biosimilar to be approved in the EU, Canada, and the United States. The FDA also approved Cimerli in early August as the country’s second ranibizumab biosimilar, second ophthalmology biosimilar, and third interchangeable biosimilar.

The EC based the approval of Ranivisio on positive data from the randomized, double-masked, parallel group, mulicenter, phase 3 COLUMBUS-AMD study. In the study, Ranivizio was found to have comparable safety and efficacy profiles with the reference product in patients with AMD.

Teva Pharmaceuticals has partnered with Bioeq, a joint venture between Polpharma Biologics and Formycon, on the commercialization of Ranivisio. Under the agreement, Bioeq has exclusive commercialization rights for the biosimilar in the EU and the United Kingdom.