On August 21, 2025, Alvotech and Advanz Pharma Holdco Limited (“Advanz”) announced that MYNZEPLI®, a biosimilar of Regeneron’s EYLEA® (aflibercept), was approved by the European Commission. MYNZEPLI® will be available as a 40 mg/mL solution in a pre-filled syringe and vial and is approved for the same adult indications as EYLEA®: neovascular (wet) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion, diabetic macular oedema, and myopic choroidal neovascularization. As we reported previously, MYNZEPLI®, also known as AVT06, was given a positive opinion and recommended for approval by the European Medicine Agency’s (“EMA”) Committee for Medicinal Products for Human Use in June 2025. MYNZEPLI® is covered by an ongoing partnership agreement between Alvotech and Advanz, under which Alvotech is responsible for development and supply and Advanz is responsible for registration and commercialization.
Additionally, on August 22, Bio-Thera Solutions (“Bio-Thera”) and STADA Arzneimittel AG (“STADA”) announced an agreement to expand their commercial partnership to BAT1806, a biosimilar of Roche’ ROACTEMRA (tocilizumab). The marketing authorization application for BAT1806 was accepted by the EMA in October 2022 and the product received marketing authorization in Europe in June 2024 for the treatment of rheumatoid arthritis and other inflammatory conditions. Under the new agreement, which is still subject to shareholder approval, Bio-Thera will be responsible for development, manufacturing, and supply of BAT1806 and STADA will have exclusive commercialization rights in the European Union, the United Kingdom, Switzerland, and select other countries. These terms are similar to the previously existing commercial partnership covering BAT2506, a biosimilar of Janssen Biotech’s SIMPONI® (golimumab).