Ocrelizumab is a therapeutic monoclonal antibody (mAb) that represents a different scientific approach to treating multiple sclerosis (MS). It is a humanized anti-CD20 mAb that targets CD20 marker on B lymphocytes, a typo of immune cell that plays a key role in the disease and serves as an immunosuppressive drug. Ocrelizumab binds selectively to CD20, which is expressed on the membrane of B cells. When ocrelizumab binds to CD20 on B cells, these cells are eliminated by antibody-dependent cell-mediated cytotoxicity and, to a lesser extent, complement-dependent cytotoxicity.
The originator product, Ocrevus (ocrelizumab), discovered and developed, and marketed by Hoffmann–La Roche's (Roche) subsidiary Genentech, was approved by the US Food and Drug Administration (FDA) in March 2017 and by the European Medicines Agency (EMA) on 8 January 2018. It is the first and only approved disease-modifying therapy for primary progressive MS (PPMS), a highly disabling form of MS. Additionally, it is the first and only medicine approved to treat two types of MS: relapsing forms of MS (RMS) and PPMS. Ocrevus is also the first and only approved MS treatment to target CD20-positive B cells. It is given once every six months by an intravenous infusion.
The patents on Ocrevus will expire in the US on 28 March 2029 and in Europe in March 2028 [1].
Xacrel clinical trial
CinnaGen has developed a follow-on biological to ocrelizumab, named Xacrel, which received approval from the Iran FDA on 17 March 2021. Currently, it is exclusively available in Iran and is indicated for RMS and PPMS [2].
CinnaGen, established in 1994, is the largest biotechnology company in Iran and is also the biggest in the Middle East and North Africa region [3].
In mid-2019, CinnaGen initiated a phase III, randomized, two-arm, double-blind, multi-centred, active-controlled, parallel study aimed at evaluating the equivalency of efficacy and safety of CinnaGen’s ocrelizumab in comparison to the reference product, Ocrevus (Roche), in patients with RMS.
The study assigned patients in a 1:1 ratio. One hundred and seventy patients with RMS, aged between 18 to 55, were enrolled. These patients had an expanded disability status scale (EDSS) between 0‒5.5, experienced at least two attacks in the last two years or had an attack in one year with neurological stability for ≥ 30 days prior to enrolling in the study. The patients received ocrelizumab. In one arm, patients received Xacrel (ocrelizumab by CinnaGen), while in the other arm, the patients received Ocrevus (ocrelizumab by Roche/Genentech). The study was completed on 1 October 2021. According to the analysis and study results, Xacrel and Ocrevus were comparable in efficacy and safety, with no significant difference [4].
Celltrion is also conducting phase III trial for its CT-P53 ocrelizumab biosimilar in the US to compare efficacy, pharmacokinetics, and safety between CT-P53 and the originator drug Ocrevus in a total of 512 relapsing-remitting MS patients [5].
Ocrevus was Roche’s top-selling pharmaceutical in 2022, according to the 2022 annual report, making US$6.7 billion global sales. Ocrevus sales are expected to rise to US$7.4 billion by 2029, while the global MS market is projected to generate sales of US$29.8 billion by 2030.
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References
1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. CinnaGen. Xacrel® [homepage on the Internet]. [cited 2023 Nov 28]. Available from: https://www.cinnagen.com/Product.aspx?t=2&l=1&Id=605
3. GaBI Online - Generics and Biosimilars Initiative. CinnaGen to invest in Turkish pharmaceuticals sector [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 28]. Available from: www.gabionline.net/pharma-news/CinnaGen-to-invest-in-Turkish-pharmaceuticals-sector
4. ClinicalTrials.gov. Efficacy and safety of Xacrel® (ocrelizumab) in participants with relapsing remitting multiple sclerosis. Available from: https://clinicaltrials.gov/study/NCT04966338
5. GaBI Online - Generics and Biosimilars Initiative. Clinical trial advances for Kashiv and Celltrion [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 28]. Available from: www.gabionline.net/biosimilars/research/clinical-trial-advances-for-kashiv-and-celltrion
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