On 2 January 2026, Samsung Bioepis announced that it has begun direct commercialisation of Byooviz®, biosimilar to Genentech’s Lucentis® (ranibizumab), in Europe, following the transfer back of commercial rights from Biogen to Samsung Bioepis.
The pre-filled syringe (PFS) presentation of Byooviz® is expected to become available in Europe from Q2 2026, following a positive opinion of the EMA’s CHMP for Byooviz® pre-filled syringe (PFS) in December 2025.
Samsung Bioepis and Biogen had partnered in November 2019 in relation to commercialisation of two ophthalmology biosimilars (Byooviz® and Opuviz™ (biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)) 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. In October 2025, Samsung Bioepis announced that it had entered into an Asset Purchase Agreement with Biogen in Europe for the two ophthalmology biosimilars.
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).