EMA recommends approval of ranibizumab, rituximab and trastuzumab biosimilars

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EMA recommends approval of ranibizumab, rituximab and trastuzumab biosimilars

Biosimilares/Novedades | Posted 24/09/2024 0 Post your comment

On 25 July 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorization for three more monoclonal antibody biosimilars: ranibizumab, rituximab, and trastuzumab.

The three approved biosimilars are Reddy Holding’s Ituxredi (rituximab), Midas Pharma’s Ranibizumab Midas (ranibizumab), and Prestige Biopharma’s Tuznue (trastuzumab).

The reference products for Ituxredi, Ranibizumab Midas, and Tuznue are Roche’s MabThera, Genentech (Roche)/Novartis’ Lucentis and Roche’s Herceptin, respectively. Table 1 presents the therapeutic areas, company, and reference product of the three newly approved monoclonal antibody biosimilars.

Table 1: EMA approved three more biosimilar monoclonal antibodies in July 2024
Product name	Active substance	Therapeutic area	Applicant	Reference product
Ituxredi	rituximab	Chronic lymphocytic leukaemia Granulomatosis with polyangiitis and microscopic polyangiitis Non-Hodgkin’s lymphoma Pemphigus vulgar Rheumatoid arthritis	Reddy Holding	MabThera - Roche
Ranibizumab Midas	ranibizumab	Neovascular (wet) age-related macular degeneration (AMD) Visual impairment due to diabetic macular oedema (DME) Proliferative diabetic retinopathy (PDR) Visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) Visual impairment due to choroidal neovascularisation (CNV)	Midas Pharma	Lucentis - Genentech (Roche)/Novartis
Tuznue	trastuzumab	Breast cancer Metastatic gastric cancer	Prestige Biopharma	Herceptin - Roche
EMA: European Medicines Agency.

Ituxredi rituximab biosimilar will be available in 100 mg and 500 mg concentrate for solution for infusion.

Ranibizumab Midas ranibizumab biosimilar will be available in 10 mg/mL solution for injection.

Tuznue trastuzumab biosimilar will be available in 150 mg and 420 mg powder for concentrate for solution for infusion.

Europe has already approved five rituximab biosimilars, four ranibizumab biosimilars, and six trastuzumabbiosimilars. Table 2 presents information about the applicants and the authorization date of these approved biosimilars [1].

Table 2: EMA-approved rituximab, ranibizumab, and trastuzumab (2017–2024) [1]
Product name	Applicant	Authorization date
Rituximab
Blitzima	Celltrion	13 Jul 2017
Rixathon	Sandoz	15 Jun 2017
Riximyo	Sandoz	15 Jun 2017
Ruxience	Pfizer	1 Apr 2020
Truxima	Celltrion	17 Feb 2017
Ranibizumab
Byooviz	Samsung Bioepis	18 Aug 2021
Ranivisio	Bioeq/Teva Pharma	25 Aug 2022
Rimmyrah	Qilu Pharma	5 Jan 2024
Ximluci	Stada Arzneimittel/Xbrane Biopharma	9 Nov 2022
Trastuzumab
Herzuma	Celltrion	8 Feb 2018
Kanjinti	Amgen/Allergan	16 May 2018
Ogivri	Biocon/Mylan	12 Dec 2018
Ontruzant	Samsung Bioepis	15 Nov 2017
Trazimera	Pfizer	26 Jul 2018
Zercepac	Accord Healthcare	27 Jul 2020
EMA: European Medicines Agency

Back in September 2022, Prestige Biopharma withdrew the Marketing Authorization Application for their Herceptin Biosimilar, Tuznue [2].

By the end of July 2024, EMA had recommended the approval of 96 biosimilars, excluding 17 that were withdrawn [1].

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Biosimilars approved in the US

Biosimilars approved in Canada

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 24]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
2. GaBI Online - Generics and Biosimilars Initiative. Forwards for Formycon’s Keytruda and backwards for Prestige’s Herceptin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Sep 24]. Available from:
www.gabionline.net/biosimilars/news/forwards-for-formycon-s-keytruda-and-backwards-for-prestige-s-herceptin

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