Biosimilars
SBR issues position statement on safe originator biological/biosimilar interchangeability
In early 2026, the Biotechnology Committee of the Brazilian Society of Rheumatology published a position statement on ‘the interchangeability of originator and biosimilar biologicals in immune-mediated rheumatic diseases’ in Advances in Rheumatology. This outlines five key recommendations for physicians.
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.
OECD study finds no direct link between advertising rules and biosimilar uptake
In December 2025, the Organisation for Economic Co-operation and Development (OECD) published a working paper titled ‘Assessing the impact of promotion and advertising regulations on biosimilar uptake’ [1].
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.
FDA approves aflibercept biosimilar Eydenzelt and label expansion for adalimumab biosimilar Yuflyma
On 9 October 2025, the US Food and Drug Administration (FDA) approved Celltrion’s Eydenzelt (aflibercept-boav), a biosimilar referencing Regeneron’s Eylea (aflibercept). On 17 October 2025, the FDA approved expanded indications for Celltrion’s Yuflyma (adalimumab-aaty) and its unbranded version.
ANVISA approves biosimilars for denosumab, trastuzumab, and aflibercept
In September 2025, ANVISA, the Brazilian Health Regulatory Agency, issued favourable opinions recommending marketing authorization for four biosimilars, including two biosimilars of denosumab, one of trastuzumab, and one of aflibercept [1].
