Denosumab biosimilars Bildyos and Bilprevda
The denosumab biosimilars to receive the positive opinion are Henlius’ Bildyos, for the treatment of osteoporosis and bone loss; and Bilprevda, for the prevention of skeletal-related events in adults with advanced malignancies involving bone.

The originator products are Amgen’s Prolia and Xgeva (denosumab). Prolia was approved by EMA for the treatment of bone resorption and postmenopausal osteoporosis and Xgeva was approved for the treatment of bone fractures and neoplasm metastasis. 

Bildyos will be available 60 mg solution for injection in vials and pre-filled syringes, while Bilprevda will be available as a 120 mg solution for injection.

Bildyos and Bilprevda were approved based on a comprehensive data package. This included structural and functional analytical data, clinical pharmacokinetic data, and a comparative clinical study. The study demonstrated that each biosimilar is highly similar to its to its respective EU-approved reference product—Bildyos to Prolia and Bilprevda to Xgeva—in terms of structure, biological activity, efficacy, safety, and immunogenicity profile.

In 2022, Henlius entered into a license and supply agreement with Organon, granting them exclusive global commercialization rights for several biosimilars, including Bildyos and Bilprevda. The agreement excludes rights for mainland China.

Both Bildyos and Bilprevda also received US FDA approval on 2 September 2025.

As of August 2025, a total of 21 denosumab biosimilars, developed by 10 different companies, have been approved in Europe [1].

Aflibercept biosimilar Eyluxvi (ALT-L9)
The aflibercept biosimilar to receive the positive opinion is Alteogen’s Eyluxvi (ALT-L9), intended for the treatment of adults with neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

The applicant and marketing authorisation holder of Eyluxvi is Biolitec Pharma Limited Zweigniederlassung Jena.

The biosimilar product will be available as a 40 mg/mL solution for injection in vials; and must only be administered by a qualified physician experienced in administering intravitreal injections.

The CHMP's positive opinion is based on a robust analytical, non-clinical, and clinical data package comparing Eyluxvi to the reference product, Regeneron’s Eylea. A randomized, double-masked, parallel-group, multicenter Phase 3 study conducted by Alteogen, demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetic (PK) profiles between Eyluxvi and reference aflibercept in patients with neovascular (wet) age-related macular degeneration (wet AMD).

Upon approval, Eyluxvi will be Alteogen's second biosimilar product. This follows Alteogen's first biosimilar, a Herceptin biosimilar (trastuzumab, ALT-L2), which was commercialized in China in 2024 by its license partner, Qilu Pharmaceutical. 

So far, a total of 11 aflibercept biosimilars from 10 companies have been approved in Europe [1].

Ustekinumab biosimilar Usrenty
The ustekinumab to receive the positive opinion is Biosimilar Collaborations Ireland Limited’s Usrenty, for the treatment of Crohn’s disease, plaque psoriasis and paediatric plaque psoriasis, and psoriatic arthritis. On 17 September 2025, Usrenty received the European Commission’s approval. 

Usrenty will be available as a 45 mg solution for injection in vials or pre-filled syringes, a 90 mg solution for injection in pre-filled syringes and a 130 mg concentrate for solution for infusion. 

Biosimilar Collaborations Ireland’s denosumab biosimilars Vevzuo and Evfraxy, as well as biosimilar pegfilgrastim Vivlipeg have been approved in April and June 2025 respectively.

This brings the total number of approved ustekinumab biosimilars in Europe to 13, from 10 different companies [1].

Related articles
EMA recommend approval for aflibercept, ustekinumab, and pegfilgrastim biosimilars 

EC approves three biosimilars, 14 more await final authorization

EMA recommends approval for three denosumab biosimilars: Bomyntra, Conexxence, and Rolcya

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe  [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 10]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe

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