Denosumab drug aliquots can be used for in vitro or in vivo experiments. For biosimilar development, different batches of Denosumab 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.
Find and order your therapeutic molecules through smart filters
Up to 10 batches of original drugs for examining batch-to-batch variations
Up to 80% less compared to the original pharmaceutical price
Shipment within days worldwide according to GDP-standards
Up to 80% less compared to the original pharmaceutical price
| Drug name | Prolia® |
| INN | Denosumab |
| API type | Denosumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology. |
| Pharmacotherapeutic group | Drugs for the treatment of bone diseases – Other drugs affecting bone structure and mineralization |
| ATC code | M05BX04 |
| Target of antibody | RANKL; Synonyms: CD254, ODF, OPGL, OPTB2, TRANCE, hRANKL2, sOdf, TNFSF11, Ly109l, OPG, Trance, cd254, odf, opgl, optb2, rankl, sodf, tnfsf11, trance |
| General function | Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing activation of its receptor, RANK, on the surface of osteoclast precursors and osteoclasts. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption in cortical and trabecular bone. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Denosumab treatment rapidly reduced the rate of bone turnover, reaching a nadir for the bone resorption marker serum type 1 C-telopeptides (CTX) (85% reduction) by 3 days, with reductions maintained over the dosing interval. At the end of each dosing interval, CTX reductions were partially attenuated from maximal reduction of ≥ 87% to approximately ≥ 45% (range 45-80%), reflecting the reversibility of Prolia’s effects on bone remodelling once serum levels diminish. These effects were sustained with continued treatment. Bone turnover markers generally reached pre-treatment levels within 9 months after the last dose. Upon re-initiation, reductions in CTX by denosumab were similar to those observed in patients initiating primary denosumab treatment. |
| Original license holder | Amgen |
| Marketing authorisation numbers | EU/1/10/618/001 EU/1/10/618/002 EU/1/10/618/003 |
| Marketing authorisation holder | Amgen Europe B.V. Minervum 7061 4817 ZK Breda The Netherlands |
| Name of the manufacturer of the biological active substance | Amgen Europe B.V. Minervum 7061 4817 ZK Breda The Netherlands Amgen Technology Ireland (ADL) Pottery Road Dun Laoghaire Co Dublin Ireland |
| Name and address of the manufacturer(s) responsible for batch release | Amgen Europe B.V. Minervum 7061 4817 ZK Breda The Netherlands |
| Max shelf life | 36 months |
| Storage conditions | 2°C – 8°C |
| List of excipients | Acetic acid, glacial* Sodium hydroxide (for pH adjustment)* Sorbitol (E420) Polysorbate 20 |
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
Am Mühlenberg 10
14476 Potsdam | Germany
