Biosimilars/News

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.

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).

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.

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).

January 2025 biosimilar approvals in Europe

Biosimilars/News | Posted 25/02/2025

On 30 January 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 for three biosimilar medicines: Dyrupeg (pegfilgrastim), Pavblu (aflibercept) and its duplicate Skojoy (aflibercept).

EC approves eight biosimilars, eight more await final authorization

Biosimilars/News | Posted 18/02/2025

The European Commission (EC) granted marketing authorization for eight biosimilars: Sandoz’s Afqlir, Formycon’s Ahzantive/Baiama, Accord Healthcare’s Absimky and Imuldosa, Samsung Bioepis’ Opuviz, Midas Pharma’s Ranibizumab Midas, and Prestige Biopharma’s Tuznue during September 2024 to January 2025.

Canada approves first omalizumab biosimilar Omlyclo

Biosimilars/News | Posted 06/02/2025

On 6 December 2024, Health Canada approved Celltrion’s Omlyclo (CT-P39) omalizumab biosimilar – the first and only omalizumab biosimilar currently available in Canada. The product is a biosimilar of Novartis’ Xolair.

EMA recommends approval for tocilizumab biosimilar Avtozma and filgrastim biosimilar Zefylti

Biosimilars/News | Posted 28/01/2025

On 12 December 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for two more biosimilars: Celltrion’s Avtozma and CuraTeQ Biologics’ Zefylti.

Ustekinumab biosimilars Yesintek, SteQeyma, and Otulfi approved by FDA, EMA and Health Canada

Biosimilars/News | Posted 21/01/2025

In late 2024 and early 2025, multiple ustekinumab biosimilars, including Yesintek, SteQeyma, and Otulfi, which are biosimilars referencing Janssen/Johnson & Johnson’s (J&J) Stelara, received regulatory approvals in the US, Europe, Canada, and the UK, expanding treatment options for Crohn’s disease, psoriasis related conditions, and ulcerative colitis.

EMA recommends approval for four denosumab biosimilars: Obodence, Osenvelt, Stoboclo, Xbryk

Biosimilars/News | Posted 15/01/2025

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the granting of marketing authorization for four denosumab biosimilars: Obodence and Xbryk (SB16), developed by Samsung Bioepis, on 14 November 2024, and Stoboclo and Osenvelt (CT-P41), developed by Celltrion, on 12 December 2024. These biosimilars are based on Amgen’s reference products Prolia and Xgeva, respectively.

EMA recommends approval of three aflibercept biosimilars: Ahzantive, Baiama, and Eydenzelt

Biosimilars/News | Posted 08/01/2025

On 14 November and 12 December 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorization for three aflibercept biosimilars: Baiama, its duplicate, Ahzantive, and Eydenzelt.

Canada approves first tocilizumab biosimilar Tyenne

Biosimilars/News | Posted 03/12/2024

On 11 October 2024, Health Canada approved Fresenius Kabi’s tocilizumab biosimilar, Tyenne – the first and only tocilizumab biosimilar currently available in Canada – which references Roche’s Actemra/RoActemra (tocilizumab).

EMA recommends approval for ustekinumab biosimilar Absimky and Imuldosa

Biosimilars/News | Posted 26/11/2024

On 17 October 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorization for Accord’s Absimky and Imuldosa, both of which are ustekinumab biosimilars referencing Janssen/Johnson & Johnson’s Stelara.

Canada approves pegfilgrastim biosimilar Armlupeg

Biosimilars/News | Posted 20/11/2024

India-based Lupin Limited (Lupin) announced on 23 August 2024 that it received marketing approval from Health Canada for its biosimilar pegfilgrastim biosimilar, which will be marketed as Armlupeg.

FDA approves fifth ustekinumab biosimilar Imuldosa

Biosimilars/News | Posted 13/11/2024

On 10 October 2024, the US Food and Drug Administration (FDA) approved Accord’s Imuldosa (ustekinumab-srlf), making it the fifth ustekinumab biosimilar referencing Janssen/Johnson & Johnson’s Stelara.

EC approval for three ustekinumab biosimilars: Eksunbi, Fymskina, Otulfi

Biosimilars/News | Posted 05/11/2024

The European Commission (EC) granted marketing authorization for three ustekinumab biosimilars: Samsung Bioepis’ Eksunbi on 12 September 2024; Formycon’s Fymskina, and Fresenius Kabi’s Otulfi on 25 September 2024.

FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli

Biosimilars/News | Posted 29/10/2024

The US Food and Drug Administration (FDA) granted approval for two biosimilars, Formycon’s FYB202/Otulfi (ustekinumab-aauz) and Samsung Bioepis’ Soliris biosimilar, Epysqli (eculizumab-aagh), on 27 September and 22 July 2024, respectively. FYB202/Otulfi, a biosimilar referencing Johnson & Johnson’s Stelara, while Epysqli is a biosimilar referencing Alexion’s Soliris.

FDA approves second strength of trastuzumab biosimilar Hercessi

Biosimilars/News | Posted 23/10/2024

On 18 September 2024, the US Food and Drug Administration (FDA) granted approval for a second strength for Accord’s Hercessi (trastuzumab-strf), a biosimilar referencing Roche’s Herceptin.

EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz

Biosimilars/News | Posted 23/10/2024

On 19 September 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorization for two aflibercept biosimilars: Sandoz’s Afqlir and Samsung Bioepis’s Opuviz. These products are biosimilars of the reference product Eylea, developed by Regeneron and Bayer.

FDA approves aflibercept biosimilars Enzeevu and Pavblu

Biosimilars/News | Posted 15/10/2024

The US Food and Drug Administration (FDA) has approved two more aflibercept biosimilars in August 2024. FDA granted approval for Sandoz’s Enzeevu (aflibercept-abzv) and Amgen’s Pavblu (aflibercept-ayyh) on 12 and 23 August 2024, respectively, making them the fourth and fifth approvals for a biosimilar referencing Eylea.

EC approvals of four biosimilars: Tofidence, Wezenla, Avzivi and SteQeyma

Biosimilars/News | Posted 08/10/2024

The European Commission (EC) granted marketing authorization for four biosimilars between June and August 2024. In August 2024, the EC approved Celltrion’s SteQeyma (ustekinumab), in July 2024, Bio-Thera’s Avzivi (bevacizumab), and in June 2024, Amgen’s Wezenla (ustekinumab) and Biogen/Bio-Thera’s Tofidence (tocilizumab).

Canada approves trastuzumab Adheroza and ustekinumab Steqeyma biosimilars

Biosimilars/News | Posted 01/10/2024

In August 2024, Henlius Biotech's trastuzumab biosimilar, Adheroza, received marketing approval from Health Canada. In July 2024, Celltrion’s ustekinumab biosimilar, Steqeyma (CT-P43), also gained Health Canada approval.

EMA recommends approval of ranibizumab, rituximab and trastuzumab biosimilars

Biosimilars/News | Posted 24/09/2024

On 25 July 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorization for three more monoclonal antibody biosimilars: ranibizumab, rituximab, and trastuzumab.

COFEPRIS approves bevacizumab Bhava and trastuzumab Mamitra biocomparables

Biosimilars/News | Posted 18/09/2024

In July 2024, the Mexican regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk, Comisión Federal para la Protección contra Riesgos Sanitarios), approved two biocomparables – bevacizumab Bhava and trastuzumab Mamitra – from India-based Zydus.

EMA recommends approval of four ustekinumab biosimilars: Eksunbi, Fymskina, Otulfi, Steqeyma

Biosimilars/News | Posted 10/09/2024

On 25 July and 27 June 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorization for four ustekinumab biosimilars.

FDA approves filgrastim biosimilar Nypozi

Biosimilars/News | Posted 04/09/2024

In addition to the biosimilars approval of Pyzchiva (ustekinumab-ttwe), with a provisional determination for interchangeability designation [1], and Ahzantive (aflibercept-mrbb) [2] on 28 June 2024, the US Food and Drug Administration (FDA) also approved Tanvex BioPharma’s Nypozi (filgrastim-txid) biosimilar, which references Amgen’s Neupogen.

FDA approves third aflibercept biosimilar Ahzantive

Biosimilars/News | Posted 13/08/2024

The US Food and Drug Administration (FDA) was busy in June 2024. On 28 June 2024, the FDA granted approval for Formycon’s Ahzantive (aflibercept-mrbb), making it the third approval for a biosimilar referencing Eylea.

Richmond to launch similar biologicals bevacizumab Yriviak and adalimumab Armixa

Biosimilars/News | Posted 06/08/2024

On 22 July 2024, the Argentina-based Laboratorios Richmond announced the launch of Yriviak, a bevacizumab similar biological, in Argentina. In the coming months, Richmond plans to launch their adalimumab similar biological, Armixa.

China approves Simcare’s cetuximab beta Enlituo

Biosimilars/News | Posted 30/07/2024

On 25 June 2024, Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group based in Nanjing, China, announced that Enlituo, a cetuximab beta injection, had received marketing approval from the China National Medical Administration (NMPA). This new-generation anti-epidermal growth factor receptor (EGFR) antibody drug was developed in collaboration with Mabpharm Limited.

FDA approves third ustekinumab biosimilar Pyzchiva

Biosimilars/News | Posted 16/07/2024

On 28 June 2024, the US Food and Drug Administration (FDA) approved a third ustekinumab biosimilar, Pyzchiva (ustekinumab-ttwe). This product has been developed by Samsung Bioepis and is commercialised by Sandoz. It is a biosimilar of reference product Johnson & Johnson’s (J&J) Stelera.

FDA approves first eculizumab biosimilar Bkemv for two rare diseases

Biosimilars/News | Posted 09/07/2024

On 28 May 2024, the US Food and Drug Administration (FDA) approved Amgen's Bkemv (eculizumab-aeeb), the first biosimilar to AstraZeneca's rare blood disorder treatment Soliris approved in the US.

EC biosimilar approvals: Omlyclo, Jubbonti/Wyost, and Pyzchiva

Biosimilars/News | Posted 03/07/2024

The European Commission (EC) granted marketing authorization for four biosimilars. They are Celltrion’s Omlyclo (omalizumab), Sandoz’s denosumab biosimilars Jubbonti and Wyost, and Samsung Bioepis’ Pyzchiva (ustekinumab). Furthermore, the EC approves expanded indication for Samsung Bioepis' Epysqli (eculizumab) to include treatment of atypical haemolytic uremic syndrome (aHUS).

EMA recommends approval of biosimilar bevacizumab Avzivi

Biosimilars/News | Posted 25/06/2024

On 30 May 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorization for Avzivi (bevacizumab), Bio-Thera Solutions’ (Bio-Thera) biosimilar of the reference product Avastin.

FDA approves first interchangeable aflibercept biosimilars to treat macular degeneration

Biosimilars/News | Posted 19/06/2024

On 20 May 2024, the US Food and Drug Administration (FDA) approved Biocon Biologic’s Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen's Opuviz (aflibercept-yszy) as the first interchangeable biosimilars to Regeneron and Bayer's Eylea (aflibercept). The Samsung Bioepis product has also been launched in South Korea under brand name, Afilivu.

FDA approves ustekinumab, trastuzumab, and tocilizumab biosimilars

Biosimilars/News | Posted 19/06/2024

In April 2024, the US Food and Drugs Administration (FDA) approved Alvotech and Teva’s Selarsdi (ustekinumab-aekn), a biosimilar to Stelara and Shanghai Henlius Biotech’s Herceptin biosimilar, Hercessi (trastuzumab-strf). This comes after the March 2024 news of the approval of Fresenius Kabi’s Tyenne (tocilizumab-aazg), the first tocilizumab biosimilar with an intravenous and subcutaneous formulation.