Biosimilars/News

ANVISA approves ranibizumab and tocilizumab biosimilars

Biosimilars/News | Posted 03/10/2025

Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA) has approved biosimilars for Lucentis (ranibizumab) and Actemra (tocilizumab), expanding treatment access for eye diseases and arthritis.

Argentina approves the first biosimilar agalsidase beta for Fabry disease

Biosimilars/News | Posted 17/09/2025

Argentina has approved Agalzyme, a biosimilar of agalsidase beta, as the first enzyme replacement therapy for Fabry disease in Latin America, representing a major advance in treatment accessibility for this rare disorder.

Hulio granted US interchangeability status

Biosimilars/News | Posted 25/08/2025

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

Biosimilars/News | Posted 14/08/2025

Paraguay takes major step forward in access to cancer treatments with first pembrolizumab similar biological.

UK MHRA approves biosimilars Zefylti (filgrastim) and Ahzantive (aflibercept)

Biosimilars/News | Posted 30/07/2025

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

Biosimilars/News | Posted 22/07/2025

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

Biosimilars/News | Posted 10/07/2025

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

Biosimilars/News | Posted 30/06/2025

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

Biosimilars/News | Posted 20/06/2025

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

Biosimilars/News | Posted 05/06/2025

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

Biosimilars/News | Posted 27/05/2025

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

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.

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 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).

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.

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.

Infliximab price wars

Biosimilars/News | Posted 04/12/2015

Merck has reportedly slashed the price of its blockbuster Remicade (Infliximab) in the UK in order to fight off growing competition from infliximab biosimilars.

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).

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)

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).

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