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].
Related articles
Biosimilars approved in the US
Biosimilars approved in Canada
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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