Biosimilars/News
Hulio granted US interchangeability status
In May 2025, the US Food and Drug Administration (FDA) announced the decision to grant interchangeability status to Mylan/Biocon’s biosimilar Hulio (adalimumab-fkjp). This biosimilar joins Samsung Bioepis’ Hadlima (adalimumab-bwwd), and a number of other adalimumab biosimilars, as interchangeable products available in the US market [1].
First pembrolizumab similar biological introduced in Paraguay
Paraguay takes major step forward in access to cancer treatments with first pembrolizumab similar biological.
UK MHRA approves biosimilars Zefylti (filgrastim) and Ahzantive (aflibercept)
In May 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved CuraTeQ’s filgrastim biosimilar Zefylti for neutropenia and PBPC mobilization. Earlier, in February 2025, it approved Formycon/Klinge Biopharma’s aflibercept biosimilar Ahzantive/FYB203 for retinal diseases.
FDA approves ustekinumab biosimilar Starjemza
On 22 May 2025, the US Food and Drug Administration (FDA) approved Bio-Thera Solutions’ Starjemza (ustekinumab-hmny), a biosimilar ustekinumab referencing Janssen/Johnson & Johnson’s Stelara.
EMA recommend approval for aflibercept, ustekinumab, and pegfilgrastim biosimilars
On 19 June 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 six biosimilars, including four aflibercept biosimilar medicines, an ustekinumab biosimilar, and a pegfilgrastim biosimilar.
FDA approves Hadlima and Otulfi as interchangeable biosimilars
In May 2025, the US Food and Drug Administration (FDA) has designated Samsung Bioepis and Organon’s Hadlima (adalimumab-bwwd) autoinjectors and prefilled syringes as the fifth interchangeable Humira biosimilar. Separately, Formycon’s Otulfi (ustekinumab-aauz) became the fourth interchangeable Stelara biosimilar.
EC approves three biosimilars, 14 more await final authorization
The European Commission (EC) granted marketing authorization for three biosimilars: Amgen’s Pavblu, CuraTeQ Biologics’s Dyrupeg, and Celltrion’s Qoyvolma, between March and June 2025.
FDA approves denosumab biosimilars Stoboclo and Osenvelt
On 28 February 2025, the US Food and Drug Administration (FDA) approved Celltrion’s Stoboclo and Osenvelt (denosumab-bmwo), a denosumab biosimilar referencing Amgen’s Prolia and Xgeva respectively.
EMA recommends approval for three denosumab biosimilars: Bomyntra, Conexxence, and Rolcya
On 23 May 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 denosumab biosimilar medicines. The products are Fresenius Kabi’s Bomyntra and Conexxence and Sandoz’s Rolcya.
FDA approves bevacizumab biosimilar Jobevne
On 9 April 2025, the US Food and Drug Administration (FDA) has approved Biocon’s Jobevne (bevacizumab-nwgd), a biosimilar bevacizumab referencing Roche’s Avastin, for intravenous (IV) use.
