Extended indication Secukinumab-bthr monotherapy for treatment of moderate to severe Plaque psoriasis in adults and elderly who are candidates for systemic therapy.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Secukinumab-bthr
Domain Chronic immune diseases
Reason of inclusion Biosimilar BS
Main indication Other chronic immune diseases
Extended indication Secukinumab-bthr monotherapy for treatment of moderate to severe Plaque psoriasis in adults and elderly who are candidates for systemic therapy.
Manufacturer Bio-Thera Solutions
Portfolio holder Bio-Thera Solutions
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2025
Expected Registration February 2026
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

References NCT05377944

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Indication extension

Other information