Eculizumab biosimilars: real-world and switching evidence
What the evidence shows
- Studies found2 studies, the crossover trials behind Epysqli and Bkemv, in which every patient took both the biosimilar and Soliris for six months each.
- The trialsFifty people with paroxysmal nocturnal haemoglobinuria, none previously treated, were given Epysqli or Soliris for six months and then switched to the other for six more; haemolysis control, transfusions and drug levels were the same on both, and no one developed antibodies. Forty-two patients did the same with Bkemv across 25 centres, with LDH equivalent at every crossover and no new safety concerns.
- Products with evidenceBkemv, Epysqli.
- What is missingNo study from India or the Gulf. Nothing in atypical haemolytic uraemic syndrome or in patients already stable on Soliris. No study from routine care.
Studies
Trials and extensions with a single switch
Patients on Soliris in a trial were moved once to the biosimilar, usually at the half-way point, and followed alongside those who stayed.
| Study | Disease | Switch | Products | Patients switched | Follow-up | What the authors report |
|---|---|---|---|---|---|---|
| Kulasekararaj 2024 Am J Hematol 2024;99(11):2108-2117 25 centres | Paroxysmal nocturnal haemoglobinuria | Single cross-over per patient between ABP 959 and reference eculizumab | Bkemv | 42 | Week 79 | Ratio of geometric least squares means of LDH at week 27 1.0628 (one-sided 97.5% upper CI 1.1576); geometric mean ratio of time-adjusted LDH area under the effect curve 0.981 (90% CI 0.9403 to 1.0239) across weeks 13 to 27, 39 to 53 and 65 to 79; all secondary efficacy endpoints comparable; no new safety concerns. |
| Jang 2023 eJHaem 2023;4(1):26-36 24 centres in eight countries | Paroxysmal nocturnal haemoglobinuria | Single cross-over at week 26 (SB12 to reference, or reference to SB12) | Epysqli | 50 | 52 weeks (cross-over at week 26) | LDH difference at week 26 and the ratio of time-adjusted LDH area under the effect curve within the equivalence margins; transfusions, pharmacokinetics and pharmacodynamics comparable; no anti-drug antibodies; adverse events in 72% on SB12 and 68% on reference. |
Ratio of geometric least squares means of LDH at week 27 1.0628 (one-sided 97.5% upper CI 1.1576); geometric mean ratio of time-adjusted LDH area under the effect curve 0.981 (90% CI 0.9403 to 1.0239) across weeks 13 to 27, 39 to 53 and 65 to 79; all secondary efficacy endpoints comparable; no new safety concerns.
LDH difference at week 26 and the ratio of time-adjusted LDH area under the effect curve within the equivalence margins; transfusions, pharmacokinetics and pharmacodynamics comparable; no anti-drug antibodies; adverse events in 72% on SB12 and 68% on reference.
No study matches this selection.
Switching evidence is what regulators, tender committees and formulary boards ask for before a change of product. EvySaif prepares interchangeability and switching dossiers and designs real-world studies for biosimilar programmes. Regulatory strategy consulting
Sources
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