On 2 December 2025, Samsung Bioepis announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Byooviz® pre-filled syringe (PFS), biosimilar to Genentech’s Lucentis® (ranibizumab).
The positive CHMP opinion follows Samsung Bioepis’ announcement in October 2025 that it had entered into an Asset Purchase Agreement with Biogen in Europe for Samsung Bioepis’ two ophthalmology biosimilars: Byooviz® (ranibizumab) and Opuviz™ (biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)).
Samsung Bioepis and Biogen had partnered in November 2019 in relation to commercialisation of the two ophthalmology biosimilars in the US, Canada, Europe, Japan and Australia. In October 2024, Biogen decided to terminate the November 2019 agreement with Samsung Bioepis within the US and Canada. In July 2025, Samsung Bioepis entered into an agreement with Harrow, under which Harrow assumes full commercial responsibility for Byooviz® and Opuviz™ in the US upon full transition of Biogen’s commercialisation rights back to Samsung Bioepis by the end of 2025.
Under the Asset Purchase Agreement announced in October 2025, Samsung Bioepis is responsible for commercialising Byooviz® in Europe from January 2026 once the transfer of commercial rights from Biogen back to Samsung Bioepis takes effect. Samsung Bioepis will launch Opuviz™ in Europe following the lapse or revocation of relevant patent(s) for Eylea®.
Byooviz® has been commercially available in several European countries since March 2023, following its approval in August 2021 (in vial form) as the first ophthalmology biosimilar in the region for the treatment of patients with nAMD, macular oedema following retinal vein occlusion (RVO), and myopic choroidal neovascularisation (mCNV). Other EU approved ranibizumab biosimilars include Formycon’s Ranivisio® (approved August 2022, being commercialised in the EU by Teva), Lupin’s biosimilar (being marketed in the EU by Sandoz); and STADA/Xbrane’s Ximluci® (approved November 2022).