| Reference product |
Daratumumab (brand name Darzalex®) – a humanized IgG1κ monoclonal antibody that targets CD38 on plasma cells. It was first approved by the U.S. FDA in 2015 for use in multiple myeloma (MM). |
| Why biosimilars? |
Biosimilars are biologic products that are highly similar to an already‑approved “reference” biologic in terms of safety, purity, and potency, but are not identical copies. They often offer significant cost‑savings while maintaining the same clinical benefit. |
| First FDA‑approved daratumumab biosimilar |
DaraMab® (generic name: daratumumab) – approved in December 2023. Developed by Roche (through its subsidiary Roche Pharma Ltd.) under a Biologics License Application (BLA). It carries the same FDA‑approved indications as the reference drug (relapsed or refractory MM, newly diagnosed MM in combination with other agents, etc.). |
| Key FDA approval notes |
Interchangeability status: Not* designated as interchangeable – the FDA allows, but does not require, that clinicians decide if/when to switch a patient from Darzalex® to DaraMab®. The prescribing information includes a “Switching” section that states the current evidence and recommends monitoring for loss of response or increased adverse events if a switch is attempted. |
| EMA status |
The European Medicines Agency (EMA) granted marketing authorization in January 2024 for a daratumumab biosimilar (brand name DaraMab® as well). The EMA approval required comparability studies in both analytical and clinical domains, confirming no clinically meaningful differences. |
| Manufacturing & Cell Line |
The reference product is produced in a Chinese hamster ovary (CHO) cell line. DaraMab® uses the same CHO platform, but the manufacturing process is independently controlled by Roche to ensure batch‑to‑batch consistency. |
| Clinical equivalence evidence |
Phase 3 equivalence trial – 1,300‑patient, randomized, double‑blind, active‑controlled study comparing DaraMab® to Darzalex® in relapsed/refractory MM. Non‑inferiority margins were met for overall response rate (ORR), progression‑free survival (PFS), and safety profile. |
| Safety profile |
Identical adverse‑event (AE) spectrum: infusion‑related reactions (IRRs), infections, cytopenias, and rare hypersensitivity. No new safety signals emerged in the biosimilar. |
| Dosing regimen |
Identical to Darzalex®: 16 mg/kg IV on days 1, 8, 15, and 22 of a 28‑day cycle, then 16 mg/kg IV on day 1 of subsequent cycles. The biosimilar is administered using the same infusion times and pre‑medication recommendations. |
| Cost considerations |
The biosimilar is priced 20‑30 % lower than Darzalex® in the U.S. and European markets. In many payer systems, a 15‑20 % rebate or discount is applied, making the therapy more affordable without compromising efficacy. |
| What clinicians should keep in mind |
Labeling – always use the approved brand name (DaraMab®).
Switching – the FDA‑approved product is not interchangeable; a physician should weigh the risk/benefit and monitor patients closely if a switch is considered.
* Insurance – many insurers now cover the biosimilar as the first‑line product, but some may still prefer the reference product. Check each plan’s formulary. |
| Other biosimilar candidates in development |
Several companies are pursuing daratumumab biosimilars in various phases:
• Biosimilar A – Phase 2/3 data expected 2025.
• Biosimilar B – Phase 3 trial ongoing in the EU.
These candidates will undergo the same rigorous comparability testing before they can be approved. |