In its June 2025 meeting, the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted positive opinions for six biosimilar medicines. The medicines include four aflibercept products (Mynzepli, Afiveg, Vgenfli and Eiyzey), one ustekinumab product (Usymro), and one pegfilgrastim product (Vivlipeg).
Additionally, on June 23, 2025, Alvotech announced that the EMA adopted a positive opinion recommending market approval of AVT06. AVT06 is Alvotech’s proposed biosimilar to Eylea® (aflibercept 2 mg) for the treatment of eye disorders such as neovascular (wet) age-related macular degeneration (AMD), macular edema, and diabetic retinopathy. In February 2025, the FDA accepted for review Alvotech and Teva’s Biologics License Application for AVT06.
Stay tuned to Big Molecule Watch as we continue to cover developments in the biosimilars industry.