Ocrelizumab drug aliquots can be used for in vitro or in vivo experiments. For biosimilar development, different batches of Ocrelizumab drug can be ordered at the same time. Several other reference drugs are also available.
The drug aliquots are generated by aliquoting (dividing and repackaging) the EU-licensed reference drug.
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Up to 10 batches of original drugs for examining batch-to-batch variations
Up to 80% less compared to the original pharmaceutical price
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Up to 80% less compared to the original pharmaceutical price
| Drug name | Ocrevus® |
| INN | Ocrelizumab |
| API type | Ocrelizumab is a recombinant humanised anti-CD20 monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology |
| Pharmacotherapeutic group | Selective immunosuppressants group |
| ATC code | L04AA36 |
| Target of antibody | B-lymphocyte antigen CD20 |
| General function | Ocrelizumab is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. Ocrevus is indicated for the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Ocrelizumab is a recombinant humanised monoclonal antibody that selectively targets CD20-expressing B cells. CD20 is a cell surface antigen found on pre-B cells, mature and memory B cells but not expressed on lymphoid stem cells and plasma cells. The precise mechanisms through which ocrelizumab exerts its therapeutic clinical effects in MS is not fully elucidated but is presumed to involve immunomodulation through the reduction in the number and function of CD20-expressing B cells. Following cell surface binding, ocrelizumab selectively depletes CD20-expressing B cells through antibody-dependent cellular phagocytosis (ADCP), antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and apoptosis. The capacity of B-cell reconstitution and preexisting humoral immunity are preserved. In addition, innate immunity and total T-cell numbers are not affected. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Treatment with Ocrevus leads to rapid depletion of CD19+ B cells in blood by 14 days post treatment (first time-point of assessment) as an expected pharmacologic effect. This was sustained throughout the treatment period. For the B cell counts, CD19 is used, as the presence of Ocrevus interferes with the recognition of CD20 by the assay. In the Phase III studies, between each dose of Ocrevus, up to 5% of patients showed B-cell repletion (> lower limit of normal (LLN) or baseline) at least at one time point. The extent and duration of B-cell depletion was consistent in the PPMS and RMS trials. The longest follow up time after the last Ocrevus infusion (Phase II study WA21493, N=51) indicates that the median time to B-cell repletion (return to baseline/LLN whichever occurred first) was 72 weeks (range 27 - 175 weeks). 90% of all patients had their B-cells repleted to LLN or baseline by approximately two and a half years after the last infusion. |
| Original license holder | |
| Marketing authorisation numbers | EU/1/17/1231/001 |
| Marketing authorisation holder | Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany |
| Name of the manufacturer of the biological active substance | Genentech Inc. 1000 New Horizons Way Vacaville CA 95688 United States |
| Name and address of the manufacturer(s) responsible for batch release | Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Whylen Germany |
| Max shelf life | 24 months |
| Storage conditions | 2°C – 8°C (for the original pharmaceutical presentation for the use in humans) |
| List of excipients | Sodium Acetate Trihydrate Glacial Acetic Acid Trehalose Dihydrate Polysorbate 20 Water for Injection |
Evidentic offers multiple batches of original drug aliquots in low binding Eppendorf tubes for research use only. We provide licence-free drug aliquots with long, short or even “negative shelf life” by storing the products at recommended temperatures (either 2-8°C or -80°C) and ensuring fully functional molecules for research purposes.
Evidentic GmbH
Martin-Buber-Str. 10
14163 Berlin
