EMA recommends approval for biosimilar omalizumab Adcomfo and pertuzumab Pebrilzo

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EMA recommends approval for biosimilar omalizumab Adcomfo and pertuzumab Pebrilzo

Biosimilares/Novedades | Posted 22/10/2026 0 Post your comment

On 17 September 2026, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending marketing authorisation for two biosimilar medicines: Alvotech’s AVT23, Adcomfo (omalizumab), and Biocon’s Pebrilzo (pertuzumab).

Adcomfo (omalizumab)
Adcomfo references Novartis’ Xolair authorised in the EU on 25 October 2005. It will be available as 75 mg, 150 mg and 300 mg solutions for injection in pre-filled syringe or pre-filled pen, for allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria.

Adcomfo (AVT23/ADL018) was developed by Alvotech with Kashiv Biosciences [2], and Advanz Pharma holds licensed commercial rights in the European Economic Area (European Union (EU), Norway, Iceland and Lichtenstein), UK, Switzerland, Canada, Australia and New Zealand [3].

Celltrion’s Omlyclo was the first omalizumab biosimilar approved in the EU on 24 May 2024. Teva's omalizumab applications are under review in the US and EU (March 2026), while CuraTeQ reported Phase 3 results for BP11 in April 2026.

Pebrilzo (pertuzumab)
Pebrilzo (Bmab 1500) references Roche’s Perjeta (pertuzumab), a HER2-targeting monoclonal antibody,authorised in the EU on 4 March 2013 [1]. It will be available as a 420 mg concentrate for solution for infusion, for the treatment of breast cancer in adults.

Pebrilzo follows Shanghai Henlius/Organon’s, Poherdy [4], approved in Europe in April 2026, in the US in November 2025 as the first interchangeable pertuzumab [5], and in China as Hanbeiyou in May 2026.

Roche/Genentech is suing Biocon in the US over Bmab 1500, with BPCIA proceedings commenced in July 2026 and an ITC complaint filed in February 2026. Pertuzumab biosimilars are also approved in India (Intas, Zydus, Enzene) and Russia (Biocad, R-Pharm), while EirGenix licensed EG1206A in Japan in June 2026.

Data submitted to the EMA demonstrate that both Adcomfo and Pebrilzo have comparable quality, safety and efficacy to their reference products, Xolair and Perjeta respectively. The European Commission will now review the applications and issue final decisions on EU marketing authorisation.

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References
1. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
2. GaBI Online - Generics and Biosimilars Initiative. Clinical trial advances for Kashiv and Celltrion [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Oct 22]. Available from: www.gabionline.net/biosimilars/research/clinical-trial-advances-for-kashiv-and-celltrion
3. GaBI Online - Generics and Biosimilars Initiative. Alvotech: rejection AVT02 in the US and new partnerships with Prolifarma and Advanz Pharma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Oct 22]. Available from: www.gabionline.net/biosimilars/news/alvotech-rejection-avt02-in-the-us-and-new-partnerships-with-prolifarma-and-advanz-pharma
4. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for pertuzumab and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Oct 22]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-for-pertuzumab-and-tocilizumab-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves Poherdy (first interchangeable pertuzumab) and Armlupeg (pegfilgrastim) biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Oct 22]. Available from: www.gabionline.net/biosimilars/news/fda-approves-poherdy-first-interchangeable-pertuzumab-and-armlupeg-pegfilgrastim-biosimilars

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