The European Commission (EC) granted marketing authorization for four biosimilars. They are Celltrion’s Omlyclo (omalizumab), Sandoz’s denosumab biosimilars Jubbonti and Wyost, and Samsung Bioepis’ Pyzchiva (ustekinumab). Furthermore, the EC approves expanded indication for Samsung Bioepis' Epysqli (eculizumab) to include treatment of atypical haemolytic uremic syndrome (aHUS).
Omlyclo (omalizumab)/Celltrion
Omlyclo (omalizumab), Celltrion's biosimilar of the reference product Xolair, received EC approval on 23 May 2024, following the positive Committee for Medicinal Products for Human Use (CHMP) opinion given in March 2024 [1]. It is the first omalizumab biosimilar approved in Europe.
Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE) in the blood and interstitial fluid and to membrane-bound form of IgE (mIgE) on the surface of mIgE-expressing B lymphocytes [2]. It is used to treat asthma, as well as nasal polyps and chronic idiopathic urticaria (itchy rash).
Denosumab biosimilar Jubbonti and Wyost/Sandoz
May 2024 also saw EC approval of Sandoz’s medicinal products, Jubbonti and Wyost (denosumab), which are biosimilars of Amgen’s reference products Prolia and Xgeva, respectively. They are approved for treatment of cancer-related bone disease and osteoporosis, respectively. The 16 May 2024 EC approval follows a positive opinion issued on 31 March 2024 by the CHMP of the European Medicines Agency (EMA) [3].
Denosumab is a humanized monoclonal antibody that is an inhibitor of the receptor activator of nuclear factor kappa-B ligand (RANKL), which works by preventing the development of osteoclasts which are cells that break down bone. It is used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone and giant cell tumour of bone [4].
The products are now the first denosumab biosimilars approved in Europe. They have already been approved by Health Canada and the US Food and Drug Administration (FDA) [5].
Pyzchiva (ustekinumab)/Samsung Bioepis
Samsung Bioepis’ Pyzchiva (ustekinumab) is a biosimilar of reference product Johnson & Johnson’s Stelera; the EU patent for which expired in January 2024. Pyzchiva received EC approval on 22 April 2024 after the EMA CHMP adopted a positive opinion in February 2024 [6]. The product will be commercialized by Sandoz under Samsung Bioepis and Sandoz’s partnership.
Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. It is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis [7].
Epysqli has expanded its indication
Samsung Bioepis' Epysqli (eculizumab), referencing Alexion’s biological product Soliris, has been approved and received marketing authorization in Europe on 29 May 2023. The EC approval comes after the EMA CHMP adopted a positive opinion on 31 March 2023 [8].
On 22 March 2024, the EC approves expanded Indication for Epysqli (Eculizumab) to include treatment of aHUS. With this latest approval, Epysqli is approved for treatments of adults and children patients with paroxysmal nocturnal haemoglobinuria (PNH) and aHUS.
Eculizumab is a humanized monoclonal antibody that is a terminal complement inhibitor. It is used to treat people with PNH [9].
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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of first omalizumab biosimilar Omlyclo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-first-omalizumab-biosimilar-omlyclo
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of omalizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-omalizumab
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of first denosumab biosimilar Jubbonti and Wyost [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-first-denosumab-biosimilar-jubbonti-and-wyost
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of denosumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
5. GaBI Online - Generics and Biosimilars Initiative. First denosumab biosimilars approved in Canada and the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/news/first-denosumab-biosimilars-approved-in-canada-and-the-us
6. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of ustekinumab biosimilar Pyzchiva [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-ustekinumab-biosimilar-pyzchiva
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
8. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of eculizumab biosimilar Epysqli [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-eculizumab-biosimilar-epysqli
9. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of eculizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 3]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-eculizumab
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