Approved Biosimilars
Switching Between 2 Biosimilars of Infliximab Does Not Impact Treatment Persistence in IBD, Study Finds
While providers are increasingly comfortable with switching patients with inflammatory bowel disease (IBD) from reference biologics to biosimilars on the basis of a wealth of reassuring data on the safety and efficacy of such transitions, there are fewer data available about switching among multiple biosimilars of the same reference.
At UEG 2019, Data Shed Light on Monitoring of Biosimilar Adalimumab, Imraldi, in IBD
Therapeutic drug monitoring is of particular importance in optimizing treatment for patients with inflammatory bowel disease (IBD) who are receiving therapy with anti–tumor necrosis (anti-TNF) drugs like adalimumab. This week, during the United European Gastroenterology (UEG) Week 2019 meeting, held in Barcelona, Spain, researchers will present new findings on monitoring serum trough levels of Samsung Bioepis' biosimilar adalimumab, Imraldi, in patients with IBD.
In IBD, Celltrion's Subcutaneous Infliximab Biosimilar Proves Noninferior to Intravenous Option
During the United European Gastroenterology Week 2019 meeting, held in Barcelona, Spain, researchers presented results of a phase 1 pivotal study of a subcutaneously administered formulation of biosimilar infliximab, CT-P13 (Remsima, Inflectra), in patients with inflammatory bowel disease (IBD).
Two Studies Report Results of Vedolizumab, Adalimumab, Ustekinumab for Ulcerative Colitis
A pair of studies appearing in The New England Journal of Medicine report on 2 separate studies of biologics in patients with moderate-to-severe ulcerative colitis: One study confirms top-line results seen earlier this year in a head-to-head study of vedolizumab and adalimumab, and the other reports on the results of a single intravenous infusion of ustekinumab followed by subcutaneous maintenance injections.
AHIP Report Cites Reference Biologics as Examples of Orphan Drug Gaming
While acknowledging the role that the Orphan Drug Act had in incentivizing drug companies to develop treatments for small populations suffering from rare diseases, America's Health Insurance Plans (AHIP) says pharmaceutical companies are using orphan drug status to create blockbuster drugs that are then used to treat other common medical conditions.
ICER to Assess Treatments for Ulcerative Colitis, Including Biosimilar Infliximab
The Institute for Clinical and Economic Review (ICER) said this week it will review the comparative clinical effectiveness and value of therapies for ulcerative colitis, including the reference infliximab product from Johnson & Johnson and biosimilar infliximab from Pfizer.
Paper Suggests That Oral Delivery of Biosimilar Infliximab, CT-P13, May Be Feasible
A paper published in Pharmaceutics describes development and validation of a production process for 5 mg tablets of infliximab, using biosimilar CT-P13 (Remsima, Inflectra), for the treatment of inflammatory bowel disease.
Patients With IBD Upset With British Columbia Switching Program
Patient organizations for those with inflammatory bowel disease (IBD) are upset with the government of British Columbia for a plan to shift patients to biosimilars over the next 6 months.
Ustekinumab Gets Expanded European Label With New Ulcerative Colitis Indication
Janssen, a unit of Johnson & Johnson, announced this week that the European Commission has approved its ustekinumab (Stelara) for the treatment of moderate to severe ulcerative colitis. Also approved in the European Union to treat plaque psoriasis, psoriatic arthritis, and Crohn disease, the biologic is the first available therapy that targets the interleukin-12 and -23 pathway.
British Columbia Starts Second Phase of Switching Patients to Biosimilars, This Time for IBD
This week, British Columbia began the process of transitioning patients with inflammatory bowel disease (IBD) to biosimilars.
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