Biosimilars/News

FDA approves Poherdy (first interchangeable pertuzumab) and Armlupeg (pegfilgrastim) biosimilars

Biosimilars/News | Posted 27/01/2026

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

Biosimilars/News | Posted 16/01/2026

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

Biosimilars/News | Posted 07/01/2026

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

Biosimilars/News | Posted 05/12/2025

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

Biosimilars/News | Posted 05/12/2025

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].

Biosimilars referencing Amgen’s Neulasta and Neupogen launch in Canada and US

Biosimilars/News | Posted 21/11/2025

Kashiv BioSciences has launched two biosimilars, Pexegra and Filra, in Canada, while Tanvex Biopharma has introduced its biosimilar, Nypozi (filgrastim-txid), to the US market, expanding patient access in North America.

EMA recommends approval for nine biosimilars

Biosimilars/News | Posted 13/11/2025

On 18 September 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 biosimilars, including seven denosumab, one golimumab, and one ustekinumab biosimilar medicines.

FDA approves six denosumab biosimilars

Biosimilars/News | Posted 20/10/2025

In August and September 2025, the US Food and Drug Administration (FDA) approved six denosumab biosimilars, expanding treatment options for patients with bone health issues.

EMA recommends approval for four biosimilars targeting three therapies

Biosimilars/News | Posted 10/10/2025

On 24 July 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 four biosimilars, including two denosumab biosimilar medicines, an aflibercept biosimilar, and an ustekinumab biosimilar.

FDA approves first interchangeable rapid-acting insulin biosimilar, Kirsty

Biosimilars/News | Posted 03/10/2025

On 15 July 2025, the US Food and Drug Administration (FDA) approved Biocon Biologics’ Kirsty (insulin aspart-xjhz), a biosimilar to Novo Nordisk’s NovoLog (insulin aspart). This approval designates Kirsty as the first and only interchangeable biosimilar for a rapid-acting insulin, a significant milestone in diabetes treatment access.

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.

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