Biosimilars

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 17October 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.

Samsung Bioepis wins Pyzchiva case; Regeneron patent rulings threaten foreign biosimilars

Biosimilars/General | Posted 30/07/2025

A US court denied J&J's injunction against Samsung Bioepis, clearing Pyzchiva's launch. However, Regeneron's win against Samsung/Formycon set a precedent allowing patent suits against foreign biosimilar makers, raising legal risks for global firms in the contentious US biologicals market.

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.

Reaching ESG goals in pharmaceutical development

Biosimilars/Research | Posted 10/06/2025

A recent article published in GaBI Journal, ‘Aligning environmental, social, and governance to clinical development: moving towards more sustainable clinical trials,’ [1] explores how regulators, pharmaceutical companies, and clinical researchers can align with environmental stewardship, social diversity, and equitable governance (ESG) goals for the efficient conduct of clinical trials, including those of biologicals and biosimilars.

What is the future for the US biosimilar interchangeability designation

Biosimilars/Research | Posted 05/06/2025

The evolving regulatory landscape of biosimilars and the concept of ‘interchangeability’ in the US, is explored in the GaBI Journal article, ‘US interchangeability designation: are we ready to cut the Gordian knot?’ [1].

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.

Biosimilar clinical efficacy studies: are they still necessary?

Biosimilars/Research | Posted 27/05/2025

A paper published in Drugs, explores the evolution in biosimilars regulatory thinking which is now moving away from the default requirement for clinical efficacy studies (CES) for approval [1]. This follows the release of European Medicines Agency's ‘draft reflection paper on a tailored clinical approach in biosimilar development’ [2] published on 1 April 2025.

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.

Chinese biosimilars go global: growth, partnerships, and challenges

Biosimilars/General | Posted 30/04/2025

Chinese biosimilars have gained global traction, with companies like Henlius and Bio-Thera securing international approvals. Despite challenges, China’s innovation and partnerships position it as a key biopharmaceutical player.

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.

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).

How the WHO is expanding access to biosimilars

Biosimilars/Research | Posted 11/04/2025

The World Health Organization (WHO) has highlighted its role in expanding global access to biosimilars in a February 2025 feature article, ‘Biosimilars: expanding access to essential biologic therapies’ [1].

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)

Stelara biosimilars enter US market with 85% discount in 2025

Biosimilars/General | Posted 28/03/2025

In February 2025, Teva Pharmaceuticals and Alvotech announced the availability of Selardsi (ustekinumab-aekn) in the US, followed by Sandoz’s Pyzchiva (ustekinumab-ttwe). These two products are biosimilars to the originator drug, Johnson & Johnson’s Stelara (ustekinumab).

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).

IFPMA publishes position on pharmacy-mediated substitution for biosimilars

Biosimilars/General | Posted 21/03/2025

In January 2025, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published a position paper, ‘Pharmacy-mediated substitution for biosimilars’.

Optimizing costs with biosimilars: Brazil's case

Biosimilars/Research | Posted 21/03/2025

The adoption of biosimilars, biological drugs similar to reference medications, has emerged as a pivotal strategy for reducing healthcare costs while maintaining efficacy and safety. A review by Azevedo, VF, et al.examines how Unimed Maringá, a private healthcare provider in Brazil, implemented a biosimilar management programme, achieving significant cost savings and broader patient access to essential therapies [1].

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.

The ustekinumab shift: biosimilars displace Stelara’s market leadership

Biosimilars/General | Posted 12/03/2025

The ustekinumab market is heating up as biosimilar developers aggressively challenge the dominance of Stelara, Johnson & Johnson’s blockbuster drug for autoimmune diseases. With eight biosimilars approved in Europe and seven in the US, the competition is fierce, and the stakes are high.

Biosimilars in low- and middle-income countries

Biosimilars/Research | Posted 05/03/2025

Biosimilars offer a viable route to treatment for those with non-communicable diseases (NCDs) living in low- and middle-income countries (LMICs). A review article published in GaBI Journal titled ‘Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries,’ offers insights into the benefits of biosimilars for better access to biologics in LMICs, focusing on data from selected emerging markets (Brazil, Colombia, Malaysia, Mexico, Nigeria, Taiwan, and Turkey).

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).

Brazilian law establishes December 16 as National Biosimilar Day

Biosimilars/General | Posted 05/03/2025

On 6 January 2025, President Luiz Inácio Lula da Silva sanctioned Law 15.087/25, officially declaring December 16 as National Biosimilar Drug Day in Brazil. The law, published in the Official Gazette of the Union, aims to raise awareness about the importance of biosimilars in the healthcare system.