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Switching Patients to Biosimilar Eculizumab

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

Certificate of Vaccination and Ordering Processes

Amgen and Samsung Bioepis have produced how to guides to facilitate a switch to their respective products, shown below.

As part of the switch process, a new certificate of vaccination will be required.

The companies have provided links on how to order drug ahead of a planned switch.

We would recommend contacting our service (aHUS Nurses nurses@nhs.net) when clinical teams switch a patient, so we can confirm which homecare company they are with, to ensure communication in relation to meningococcal and factor H autoantibody monitoring is with the correct company

Switching to Bekemv

Licensing:

  • Bekemv is NOT licensed for children 2 and under

 

Certificates of vaccination:

 

Content provided by Amgen to support switch – please note the first dose of Bekemv will need to be administered in hospital.

A guide to transitioning patients from Originator Eculizumab to BEKEMV

A guide to transitioning patients to Bekemv if using HealthNet Homecare

HCP guide to completing vaccination certificate for obtaining Bekemv

Bekemv Fact Sheet UK

Amgen – Biosimilar Brochure for patients

 

Order form for Bekemv

How to order Bekemv

 

 

Switching to Epysqli

Licensing:

  • Epysqli can be used in any age

 

Certificates of vaccination:

 

Content provided by Samsung Bioepis to support switch – please note the first dose of Epysqli may be given in hospital or at home and is the decision of the clinical team

A guide to transitioning patients to Epysqli

 

Order form for Epysqli

Epysqli Order Form

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