Bio101 Medicine 03 June 2025 Extended indication Bio101 monotherapy for the treatment of COVID-19 pneumonia in hospitalized adults and the elderly. Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Bio101 Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication COVID-19 Extended indication Bio101 monotherapy for the treatment of COVID-19 pneumonia in hospitalized adults and the elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Biophytis Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Fabrikant: Biophytis Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2025 Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration BIO101 350mg bid References NCT04472728 Additional remarks Expected patient volume per year Patient volume < 10 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Coronadashboard. Rijksoverheid (1); Expertopinie (2). Additional remarks In 2023 waren er 857 intensive care opnames van COVID patiënten (1). Het aantal patiënten dat mogelijk in aanmerking komt voor dit middel wordt niet hoger ingeschat dan 10 (2). Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks