FDA approves Pfizer's biosimilar, ABRILADA ™ (adalimumab-afzb) for multiple inflammatory conditions
Pfizer Inc. (NYSE: PFE) announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira® (adalimumab),(1) for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.(2)
CONCLUSIONS: Our study showed no relevant changes in the clinical outcomes following the introduction of infliximab-biosimilar. The few observed differences observed can be explained mainly by a selective switching to infliximab-biosimilar in patients with lower burden of disease. PMID: 32828145 [PubMed - as supplied by publisher]
ConclusionThe CT-P13 safety profile appears consistent with previous studies for CT-P13 and reference infliximab, supporting the favourable risk/benefit balance for CT-P13 treatment.
ConclusionThe safety profile of adalimumab was consistent with previous findings and no new safety signals were observed.
CONCLUSION: Based on our systematic review, the epidemiology of IMIDs among immigrants varies according to native and host countries, immigrant generation, and IMID type. The rapid evolution suggests a role for non-genetic factors and gene-environment interactions. Future studies should focus on these pattern shifts, given implications of rising global burden of IMIDs and immigration. PMID: 31351784 [PubMed - as supplied by publisher]
This study evaluated the impact of the HUMIRA Complete Pro (HCPro) online prescription management system on the rate of abandonment and the time to first fill for patients prescribed adalimumab (ADA). A retrospective cohort analysis of patients initiating ADA treatment with or without use of the HCPro online prescription processing system was used to evaluate the impact of HCPro on treatment initiation outcomes.MethodsPatient-level data for patients with an ADA prescription processed through HCPro were mapped to Symphony Health claims for patients initiating ADA between January 2012 and January 2015. The sample included pa...
ConclusionThere was a preference for etanercept among pregnancies with AS/JIA/PsA/PsO/RA, despite the availability of other TNFis. Decline in TNFi use after the first trimester may be related to the desire to reduce TNFis transplacental transfer and to minimize infection risk to the fetus or baby associated with live vaccine immunizations after birth.
ConclusionsWhile available data have not identified significant risks associated with a single switch between reference and biosimilar infliximab, the studies available currently report on only single switches and were mostly observational studies lacking control arms. Additional data are needed to explore potential switching risks in various populations and scenarios.
AbstractSB5 (Imraldi®) is a biosimilar of the reference anti-TNF monoclonal antibody adalimumab. It is approved for use in the following indications for which reference adalimumab is approved: rheumatoid arthritis (RA), juvenile idiopathic arthritis [polyarticular juvenile idiopathic arthritis (pJIA) and enthesitis-related arthritis (ERA)], axial spondyloarthritis [ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)], psoriatic arthritis (PsA), psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa (HS), Crohn ’s disease, pediatric Crohn’s disease, ulcerative colitis...
ZURICH (Reuters)—Novartis said its Sandoz division received approval from the European Commission for its biosimilar Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases. Zessly is approved for use in all indications of the reference medicine including rheumatoid arthritis, adult and pediatric Crohn’s disease, adult and pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis,... [Read More]
The committee favors marketing the infliximab biosimilar product Zessly for treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.International Approvals