The following is intended to help local clinical teams switch to biosimilar eculizumab.
- Due to the lack of evidence currently available in pregnancy we do not recommend biosimilar use in pregnancy, or patients actively planning pregnancy
- Bekemv (Amgen) is not licensed for the under 2’s and patients with hereditary fructose intolerance, and should NOT be used in these patients.
- Epysqli (Samsung) does not have this restriction and can be used in all ages
Homecare:
Both Bekemv and Epysqli will be pharma funded for homecare. Below is a list of homecare providers and which brand of eculizumab they are able to access.
Homecare provider |
Bekemv (Amgen) |
Epysqli (Samsung Bioepis) |
Soliris (Alexion) |
|
|
|
|
Sciensus |
Yes |
|
Yes |
Lloyds Homecare |
|
|
Yes |
Alcura |
Yes |
|
Yes |
HealthNet |
Yes |
Yes |
|
Teaching of homecare nurses
We have always provided teaching to the homecare nurses in Sciensus, Lloyds and Alcura. As both Amgen and Samsung Bioepis are using HealthNet, we have also provided teaching to these nurses about aHUS, troubleshooting, and the needs of our patients.
Monitoring after biosimilar switch
Complement blockade bloods: We recommend these are sent to Newcastle PRE 4th dose of biosimilar eculizumab to assess if adequate complement blockade has been achieved – if patient is on homecare they will need to be brought back to hospital the day before eculizumab in order to obtain trough readings.
Monitoring (meningococcal and factor H autoantibodies)
- At present, this is done via homecare for patients receiving homecare eculizumab, and is co-ordinated by the aHUS Nurses
- Amgen have agreed we can use the existing model for patients managed on Bekemv
- Samsung Bioepis have also agreed they will offer the same level of service for patients managed on Epysqli