Biosimilars
EMA recommends nine biosimilars for approval including trastuzumab and denosumab
On 25 April 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending the granting of a marketing authorization for nine biosimilar medicines. These include one trastuzumab biosimilar and eight denosumab biosimilars.
Australia biosimilar approvals in early 2025
In early 2025, Australia's medicines regulatory agency, the Therapeutic Goods Administration (TGA), approved several biosimilars, including: Celltrion’s Stoboclo and Osenvelt (denosumab) and Eydenzelt (aflibercept), and Sandoz’s Tyruko (natalizumab).
Australia approves ustekinumab biosimilar Uteknix
Australia’s medicines regulatory agency, the Therapeutic Goods Administration (TGA), approved Alvotech/Cipla’s ustekinumab biosimilar, Uteknix, on 11 February 2025.
Chinese biosimilars go global: growth, partnerships, and challenges
Chinese biosimilars have gained global traction, with companies like Henlius and Bio-Thera securing international approvals. Despite challenges, China’s innovation and partnerships position it as a key biopharmaceutical player.
EC approves eight biosimilars, six more await final authorization
The European Commission (EC) granted marketing authorization for eight biosimilars: Biocon’s Yesintek,Celltrion’s Avtozma, Eydenzelt, Osenvelt and Stoboclo; Samsung Bioepis’ Obodence and Xbryk, and CuraTeQ Biologics’ Zefylti in February 2025.
EMA recommends approval for three biosimilars: Jubereq, Osvyrti, and Qoyvolma
On 27 March 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending the granting of a marketing authorization for three biosimilar medicines: Accord’s Jubereq and Osvyrti (denosumab), and Celltrion’s Qoyvolma (ustekinumab).
How the WHO is expanding access to biosimilars
The World Health Organization (WHO) has highlighted its role in expanding global access to biosimilars in a February 2025 feature article, ‘Biosimilars: expanding access to essential biologic therapies’ [1].
FDA biosimilar approvals in March 2025: Bomyntra, Conexxence, and Omlyclo
In March 2025, the US Food and Drug Administration (FDA) approved three biosimilars: Omlyclo (omalizumab-igec), the first and only biosimilar designated as interchangeable with Xolair, as well as Bomyntra and Conexxence (denosumab-bnht), which reference Xgeva and Prolia (denosumab)
Stelara biosimilars enter US market with 85% discount in 2025
In February 2025, Teva Pharmaceuticals and Alvotech announced the availability of Selardsi (ustekinumab-aekn) in the US, followed by Sandoz’s Pyzchiva (ustekinumab-ttwe). These two products are biosimilars to the originator drug, Johnson & Johnson’s Stelara (ustekinumab).
Canada approves pegfilgrastim biosimilar Pexegra
On 25 February 2025, Health Canada granted marketing authorization to India-based Kashiv BioSciences for its pegfilgrastim biosimilar, Pexegra, which references Amgen’s Neulasta (pegfilgrastim).
