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.
Filgrastim biosimilar Zefylti
On 13 May 2025, Aurobindo Pharma announced that its wholly owned step-down subsidiary, CuraTeQ Biologics, has received marketing authorization from the UK’s MHRA for Zefylti, a biosimilar of filgrastim.
This milestone follows the European Commission’s approval of Zefylti in February 2025 [1], enabling its entry into the European Union market. Zefylti is now the second CuraTeQ biosimilar to be approved by the MHRA, after Bevqolva (a bevacizumab biosimilar), which gained authorization in December 2024.
Indications: Zefylti is approved for the treatment of neutropenia and for mobilizing peripheral blood progenitor cells (PBPCs).
Aflibercept biosimilar Ahzantive/FYB203
On 25 February 2025, Formycon and its licencing partner Klinge Biopharma, jointly announce that the UK MHRA has approved Ahzantive/FYB203 (aflibercept), a biosimilar to Eylea.
The approval of Formycon’s Ahzantive (aflibercept) in the UK covers the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal conditions, including Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV) and Macular Edema following Retinal Vein Occlusion (RVO). Ahzantive/FYB203 has already been approved in Europe [3] and the US [4].
Formycon and Teva Pharmaceuticals (Teva) has entered into a partnership for the semi-exclusive commercialization of FYB203 across major parts of Europe, including the UK, and Israel. Formycon had concluded a product supply agreement with Teva. Teva already markets Formycon’s FYB201 ranibizumab biosimilar (Ongavia) in the UK and can leverage its existing commercial infrastructure and well-established ophthalmology distribution channels synergistically.
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References
1. GaBI Online - Generics and Biosimilars Initiative. EC approves eight biosimilars, six more await final authorization Latina[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jul 30]. Available from: www.gabionline.net/biosimilars/news/ec-approves-eight-biosimilars-six-more-await-final-authorization
2. GaBI Online - Generics and Biosimilars Initiative. January 2025 biosimilar approvals in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jul 30]. Available from: www.gabionline.net/biosimilars/news/january-2025-biosimilar-approvals-in-europe
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves third aflibercept biosimilar Ahzantive [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jul 30]. Available from: www.gabionline.net/biosimilars/news/fda-approves-third-aflibercept-biosimilar-ahzantive
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