Biosimilars/News
FDA approves denosumab biosimilar Ponlimsi
On 30 March 2026, the US Food and Drug Administration (FDA) approved Teva Pharmaceuticals’ Ponlimsi (denosumab-adet), a biosimilar to Amgen’s Prolia and Xgeva (denosumab) [1].
EMA recommends approval of three new biosimilars for diabetes and autoimmune conditions
Bysumlog (insulin lispro), Dazparda (insulin aspart), and Fubelv (etanercept) receive positive CHMP opinions
On 26 February 2026, 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: Bysumlog (insulin lispro), Dazparda (insulin aspart), and Fubelv (etanercept).
EMA recommends approval for pertuzumab and tocilizumab biosimilars
On 26 February 2026, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions positive opinions, recommending the granting of a marketing authorization for two biosimilar medicines: Henlius’ Poherdy (pertuzumab) and Gedeon Richter’s Tuyory (tocilizumab). Additionally, Henlius marks the first anniversary of the European Commission’s (EC) approval of its novel biological, Hetronifly (serplulimab).
FDA approves filgrastim biosimilar Filkri
On 15 January 2026, the US Food and Drug Administration (FDA) approved the first biosimilar of the year, Accord Biopharma’s Filkri (filgrastim-laha), a biosimilar to Amgen’s Neupogen (filgrastim).
EC approves golimumab biosimilar Gotenfia and ranibizumab biosimilar Ranluspec
On 10 February 2026, the European Commission (EC) granted marketing authorization for two biosimilars: Bio-Thera/Stada’s Gotenfia (golimumab); and Lupin/Sandoz’s Ranluspec (ranibizumab), both received the positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use on 11 December 2025.
EMA recommends approval for teriparatide biosimilar Zandoriah
On 26 February 2026, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinion, recommending the granting of a marketing authorization for CinnaGen’s teriparatide biosimilar, Zandoriah, for the treatment of osteoporosis.
FDA approves third interchangeable ranibizumab biosimilar Nufymco
On 18 December 2025, the US Food and Drug Administration (FDA) granted approval to Nufymco (ranibizumab-leyk), an interchangeable biosimilar to Genentech’s Lucentis (ranibizumab).
FDA approves Poherdy (first interchangeable pertuzumab) and Armlupeg (pegfilgrastim) biosimilars
On 13 November 2025, the US Food and Drug Administration (FDA) approved Shanghai Henlius Biologics’ Poherdy (pertuzumab-dpzb) as an interchangeable biosimilar to Genentech’s Perjeta. Additionally, on 28 November 2025, the FDA approved Lupin’s pegfilgrastim biosimilar, Armlupeg (pegfilgrastim-unne).
EMA recommends approval for insulin glargine biosimilar Ondibta and denosumab biosimilar Osqay
On 13 November 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions positive opinions recommending the granting of a marketing authorization for two biosimilar medicines: Ondibta (insulin glargine), for the treatment of diabetes mellitus; and Osqay (denosumab), for the treatment of osteoporosis and bone loss.
FDA approves denosumab biosimilars Osvyrti and Jubereq, Boncresa and Oziltus
The US Food and Drug Administration (FDA) approved four denosumab biosimilars in late 2025. The first two, Osvyrti and Jubereq (denosumab-desu), were approved on 29 October 2025, and reference Amgen’s Prolia and Xgeva, respectively. The second pair, Boncresa and Oziltus (denosumab-mobz), were approved on 19 December 2025, and also reference Prolia and Xgeva.
