Menu

Biosimilars/News

Bevacizumab 1 V14f01

FDA approves bevacizumab biosimilar Jobevne

Biosimilars/News | Posted 22/05/2025

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.

Bone cells V17C04

EMA recommends nine biosimilars for approval including trastuzumab and denosumab

Biosimilars/News | Posted 11/05/2025

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 flag V13C29

Australia biosimilar approvals in early 2025

Biosimilars/News | Posted 06/05/2025

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).

Plaque Psoriasis Stada v24K25

Australia approves ustekinumab biosimilar Uteknix

Biosimilars/News | Posted 30/04/2025

Australia’s medicines regulatory agency, the Therapeutic Goods Administration (TGA), approved Alvotech/Cipla’s ustekinumab biosimilar, Uteknix, on 11 February 2025.

20893354_l

EC approves eight biosimilars, six more await final authorization

Biosimilars/News | Posted 22/04/2025

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. 

ST002293

EMA recommends approval for three biosimilars: Jubereq, Osvyrti, and Qoyvolma

Biosimilars/News | Posted 11/04/2025

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).

DNA-Helix Serendipity V13K22

FDA biosimilar approvals in March 2025: Bomyntra, Conexxence, and Omlyclo

Biosimilars/News | Posted 07/04/2025

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)

48 MD002137

Canada approves pegfilgrastim biosimilar Pexegra

Biosimilars/News | Posted 21/03/2025

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). 

106 MD002160

Insulin aspart and denosumab biosimilars approved in US

Biosimilars/News | Posted 12/03/2025

In February 2025, the US Food and Drug Administration (FDA) approved Sanofi-Aventis’ Merilog (insulin aspart-szjj), referencing NovoNordisk’s NovoLog (insulin aspart); and Samsung Bioepis’ Ospomyv and Xbryk (denosumab-dssb), referencing Amgen’s Prolia and Xgeva, respectively. Additionally, the FDA granted a provisional determination of interchangeability designation for both Ospomyv and Xbryk with its reference medicines.

Rheumatology.org V13H09

FDA approves tocilizumab biosimilar Avtozma

Biosimilars/News | Posted 05/03/2025

On 24 January 2025, the US Food and Drug Administration (FDA) has approved tocilizumab biosimilar, Avtozma (tocilizumab-anoh). Celltrion’s Avtozma (tocilizumab-anoh)/CT-P47 is a biosimilar referencing Roche/Genentech’s Actemra/RoActemra (tocilizumab).