Full approval for Lucentis biosimilar

30 Aug 2022

Full approval for Lucentis biosimilar

Following the UK and the US, the European Medicines Agency (EMA) has now also said “yes”. A German-Polish joint biosimilar to Lucentis® (ranibizumab injection) has received approval in the European Union for the treatment of several severe retinal diseases.

The consortium of companies Polpharma Biologics Group BV, Formycon AG and Bioeq AG is pleased to announce that the European Commission has granted marketing authorization for Ranivisio® (Ranivisio - ranibizumab), a biosimilar to Lucentis® (ranibizumab injection), for the treatment of multiple severe retinal diseases. The EU approval follows a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) in June 2022 and applies to all 27 EU Member States of the plus Iceland, Norway and Liechtenstein.

FYB201/Ranivisio was developed by Bioeq, a joint venture between Polpharma Biologics and Formycon. In mid-2021, Teva Pharmaceutical Industries Ltd. entered into a strategic partnership for the exclusive commercialization of FYB201 in Europe and select other countries. The launch across Europe is planned for next year, and the drug is already available in the UK under the brand name Ongavia®ii3 following approval by the Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.

At the beginning of August, the U.S. Food and Drug Administration (FDA) had followed the British and signaled the green light. A license agreement has been signed with Coherus BioSciences, Inc. for the exclusive commercialization of FYB201 in the U.S. under the trade name CIMERLI™ at the end of 2019. The marketing launch for CIMERLI™, in 0.3mg and 0.5 mg dosage forms, is scheduled by Coherus for early October 2022 in the US.

Ranivisio is indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD), the treatment of visual impairment due to diabetic macular edema (DME) or choroidal neovascularization (CNV), the treatment of proliferative diabetic retinopathy (PDR), and the treatment of visual impairment due to macular edema resulting from retinal vein occlusion (branch RVO or central RVO).

Formycon, based in Martinsried, Germany, has two further biosimilar projects already in phase III clinical development. In an asset restructuring among the shareholders (i. a. the Strüngmann brothers) and the closing of the transaction with ATHOS KG, the shareholding structure in these biosimilar candidates had changed: Formycon now owns 100% of the rights to FYB202 (previously 24.9%) and 50% of the rights (previously full out-licensing with royalty participation) to FYB201 - the just approved Lucentis analog. The participation model for FYB203 is out-licensing to Klinge Biopharma GmbH. Here, Formycon will participate in future product sales via corresponding royalties.