Extended indication Multiple Myeloma; Hematopoietic Stem Cell Transplantation
Therapeutic value Possible equal value
Registration phase Positive CHMP opinion

Product

Active substance Plerixafor
Domain Hematology
Reason of inclusion Generic
Main indication Stem cell transplants
Extended indication Multiple Myeloma; Hematopoietic Stem Cell Transplantation
Current proprietary name Mozobil (Genzyme)
Already available biosimilars / generics geen
Proprietary name Plerixafor Accord
Manufacturer Accord Healthcare
Mechanism of action Receptor antagonist
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments Alpha chemokine receptor CXCR4 antagonist.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2021
Expected Registration December 2022
Registration phase Positive CHMP opinion
Additional comments Positieve opinie in oktober 2022. SPC van het originele product verloopt per 3 augustus 2024.

Therapeutic value

Therapeutic value Possible equal value

Expected patient volume per year

Patiëntvolume is niet van toepassing bij generieke geneesmiddelen of biosimilars.

Expected cost per patient per year

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

Potential total cost per year

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.