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Summary

Samenvatting Biosimilars

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Dit is een samenvatting van het gastcollege over biosimilars.

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  • January 8, 2024
  • 3
  • 2023/2024
  • Summary
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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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