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).
Avzivi (bevacizumab)/Bio-Thera Solutions
Avzivi (bevacizumab), Bio-Thera Solutions’ biosimilar of the reference product Avastin (Roche), received EC approval on 26 July 2024, following the positive Committee for Medicinal Products for Human Use (CHMP) opinion received on 30 May 2024 [1]. Avzivi is developed and manufactured by Bio-Thera and will be commercialized by Sandoz according to their September 2021 licensing agreement.
Avzivi is approved for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer (NSCLC), renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
Avzivi is now available as a 25 mg/mL concentrate solution for infusion in Europe.
Avzivi (bevacizumab-tnjn) is also approved in the US on 6 December 2023 [2].
Ustekinumab biosimilars: SteQeyma/Celltrion and Wezenla/Amgen
On 22 August and 20 June 2024, the EC granted approval for two ustekinumab biosimilars: Celltrion’s SteQeyma and Amgen’s Wezenla, respectively. Both are biosimilars of Johnson & Johnson’s Stelara (ustekinumab).
Both Amgen’s Wezenla [3] and Celltrion’s SteQeyma [4] were approved for the treatment of Crohn’s disease, paediatric plaque psoriasis, plaque psoriasis, psoriatic arthritis.
Both Wezenla and SteQeyma are available in in both subcutaneous and intravenous forms. The subcutaneous injection comes in two strengths: 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial.
Wezenla was the first biosimilar of Stelara approved in the US in 2023 [5], and in Canada, it has been approved under the name of Wezlana [6].
SteQeyma was also approved in Canada on 31 July 2024 [7].
SteQeyma is Celltrion’s seventh biosimilar approved for use in the European Union (EU) [8].
Tofidence (tocilizumab)/Biogen and Bio-Thera
Tofidence (tocilizumab), Biogen and Bio-Thera Solutions’ biosimilar of the reference product Actemra (Roche), received EC approval on 20 June 2024, following the positive Committee for Medicinal Products for Human Use (CHMP) opinion given on 25 April 2024 [2].
The approval is for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and coronavirus disease 2019 (COVID-19), in both subcutaneous and intravenous formulations, and is now available as a 20 mg/mL concentrate for solution for infusion.
Tofidence is now the second tocilizumab biosimilar available in Europe, following Fresenius Kabi’s Tyenne [9].
Related article
FDA approves first tocilizumab biosimilar Tofidence
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References
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2. GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Avzivi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 8]. Available from: www.gabionline.net/biosimilars/news/fda-approves-bevacizumab-biosimilar-avzivi
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4. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of four ustekinumab biosimilars: Eksunbi, Fymskina, Otulfi, Steqeyma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 8]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-four-ustekinumab-biosimilars-eksunbi-fymskina-otulfi-steqeyma
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ustekinumab biosimilar Wezlana [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 8]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ustekinumab-biosimilar-wezlana
6. GaBI Online - Generics and Biosimilars Initiative. Three more biosimilar approvals in Canada in 2023 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 8]. Available from: www.gabionline.net/biosimilars/news/three-more-biosimilar-approvals-in-canada-in-2023
7. GaBI Online - Generics and Biosimilars Initiative. Canada approves trastuzumab Adheroza and ustekinumab Steqeyma biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 8]. Available from: www.gabionline.net/biosimilars/news/canada-approves-trastuzumab-adheroza-and-ustekinumab-steqeyma-biosimilars
8. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 8]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
9. GaBI Online - Generics and Biosimilars Initiative. EC approval of natalizumab, aflibercept and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 8]. Available from: www.gabionline.net/biosimilars/news/ec-approval-of-natalizumab-aflibercept-and-tocilizumab-biosimilars
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