Cost savings from infliximab biosimilars ‘insufficient’ to promote use in US @HealioGastrohttps://www.healio.com/rheumatology/practice-management/news/online/%7Bd93fd7f2-ce4c-4764-bbf0-c041cbd100f2%7D/cost-savings-from-infliximab-biosimilars-insufficient-to-promote-use-in-us …
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There have been a couple of head to head trials—here is one with infliximab-dyyb (Inflectra) vs Remicade in
#Crohns https://www.ncbi.nlm.nih.gov/m/pubmed/30929895/?i=1&from=ye%20infliximab%20biosimilar … Efficacy, safety, immunogenicity were the same -
Exactly what I was looking for! I wonder if there will be similar studies done across medications between Remicade & Humira biosimilars and one against Entyvio to mimic the VARSITY trial?
- Još 2 druga odgovora
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“Per FDA, Biosimilars go through an abbreviated approval pathway. Clinical trials are not required, at least one comparative, randomized controlled trial (RCT) in a select sensitive patient population is expected. Dose ranging studies are not required.”
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So, no, those studies would most likely no be conducted
- Još 2 druga odgovora
Novi razgovor -
Čini se da učitavanje traje već neko vrijeme.
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