Summary
Samenvatting Biosimilars
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Dit is een samenvatting van het gastcollege over biosimilars.
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Biosimilars (Barbier) Kunnen nooit exact hetzelfde zijn door inherente variabiliteit (post-translationele modificaties)
Nooit klinisch significant verschillend van RP (werkzaamheid of veiligheid)
Waarom goed?
o Prijsdaling door competitie
o Meer toegang tot therapie
o Incentive/budget voor innovatie
Ontwikkeling
1. Analyse van 10-20 batches van RP CQAs (karakterisatie, MoA, sequentie, …) fingerprint van
RP + inherente variatie
2. DNA dat codeert voor AZ sequentie gecloned in producer cel clones
3. Analyse clones voor
o Gelijkaardigheid aan RP
o Voldoende productie om kosten-effectief te producteren
Patienten trials zijn veel minder belangrijk, eerder bevestigend
Doel: aantonen dat er geen klinisch significant verschil is tov RP biosilimariteit
Vergelijkingsstudies
1) Kwaliteitsstudies
2) Preklinische studies
3) Klinische studies
o Elke stap bepaalt uitgebreidheid van volgende residuele onzekerheid beantwoorden
o Totality of evidence voor similarity heel belangrijk
Productieverandering (scaling up, betere efficientie, vernieuwing, …) comparability exercise
o Product pre and post productieverandering gelijkende kwaliteitsattributen
Residuele onzekerheid
o Risk management plan
o Farmacovigilantie
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