Biosimilars/News
FDA approves third interchangeable insulin glargine biosimilar Langlara
On 30 April 2026, the US Food and Drug Administration (FDA) approved Sunshine Lake Pharma’ Langlara (insulin glargine-aldy) as an interchangeable biosimilar to Sanofi’s Lantus.
EMA recommends approval for ranibizumab biosimilar Rexatilux
On 23 April 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 Intas’ ranibizumab biosimilar, Rexatilux, for the treatment of wet macular degeneration.
Japan approves Samsung-Nipro’s ustekinumab biosimilar
In December 2025, Samsung Bioepis and NIPRO announced the marketing approval of Ustekinumab BS Subcutaneous Injection 45mg Syringes 'NIPRO' has been granted in Japan.
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, 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).
