On12 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.
Avtozma
Celltrion’s Avtozma (CT-P47) is a biosimilar referencing Roche’s Actemra/RoActemra (tocilizumab).
Avtozma is approved for all indications of its reference product, including the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), giant cell arteritis (GCA), CAR-T cell-induced severe or life-threatening cytokine release syndrome (CRS) and coronavirus disease 2019 (COVID-19).
The positive CHMP opinion for Avtozma was supported by a comprehensive data package and totality of evidence demonstrating its biosimilarity to RoActemra, with no clinically meaningful differences in efficacy, pharmacokinetic (PK) equivalence, safety or immunogenicity.
Avtozma will be available as 20 mg/mL concentrate for solution for infusion and a 162 mg solution for injection in pre-filled syringe or pre-filled pen.
Europe’s first tocilizumab biosimilar Tyenne by Fresenius Kabi was approved on 20 July 2023 [1, 2]. The second tocilizumab biosimilar, Tofidence from Biogen, was approved on 20 June 2024 [3, 4]. Avtozma is the third tocilizumab biosimilar approved in the European Union.
Zefylti
CuraTeQ Biologics’ (CuraTeQ) Zefylti (BP13) is a biosimilar referencing Amgen’s Neupogen (filgrastim) [5].
Zefylti is approved for the treatment of neutropenia and the mobilization of peripheral blood progenitor cell. It will be available as 30 MU/0.5 mL and 48 MU/0.5 mL solution for injection or infusion in pre-filled syringe.
CuraTeQ is a wholly owned subsidiary of Aurobindo Pharma Ltd. Zefylti (BP13) is Aurobindo’s first biosimilar to receive a positive opinion from the EMA’s CHMP. Two additional products, biosimilars of pegylated filgrastim (BP14) and trastuzumab (BP02), are currently under review with the EMA, while a biosimilar to bevacizumab (BP01) is under review with UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
The latest filgrastim biosimilar approval was Nypzi by the US Food and Drug Administration (FDA) [6].
The filgrastim biosimilar market size grew from US$1.02 billion in 2023 to US$1.1 billion in 2024. It is expected to reach US$1.66 billion by 2028, driven by an aging population and increased access to health care. North America was the largest region in the filgrastim biosimilar markets in 2023.
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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of first aflibercept and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jan 28]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-first-aflibercept-and-tocilizumab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. EC approval of natalizumab, aflibercept and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jan 28]. Available from: www.gabionline.net/biosimilars/news/ec-approval-of-natalizumab-aflibercept-and-tocilizumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of biosimilar tocilizumab Tofidence and ustekinumab Wezenla [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jan 28]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-biosimilar-tocilizumab-tofidence-and-ustekinumab-wezenla
4. GaBI Online - Generics and Biosimilars Initiative. EC approvals of four biosimilars: Tofidence, Wezenla, Avzivi and SteQeyma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jan 28]. Available from: www.gabionline.net/biosimilars/news/ec-approvals-of-four-biosimilars-tofidence-wezenla-avzivi-and-steqeyma
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of filgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jan 28]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-filgrastim
6. GaBI Online - Generics and Biosimilars Initiative. FDA approves filgrastim biosimilar Nypozi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jan 28]. Available from: https://gabionline.net/biosimilars/news/fda-approves-filgrastim-biosimilar-nypozi
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