Clinical

The biosimilar CPT-13 (Remsima) is currently approved in Europe for all uses for which the originator infliximab (Remicade) is approved, including Crohn disease (CD) and ulcerative colitis (UC), which are often referred to collectively as IBD. 
 
The Center for Biosimilars® recaps the top stories for the week of January 6.
 
It is the only biosimilar candidate referencing Soliris to be granted investigational new drug approval in China.
Two studies recently reported on Hulio, the adalimumab biosimilar marketed and developed by Mylan and its partner Fujifilm Kyowa Kirin Biologics.
Zirabev, which references Avastin, will be priced at a wholesale acquisition cost (WAC) of $61.34 per 10 mg, representing a 23% discount to the WAC of Avastin, Pfizer said.
Using the biosimilar resulted in a significantly lower drug acquisition cost, at $533.40 in the biosimilar group versus $1261.90 in the reference group.
While anti–tumor necrosis factor (anti-TNF) drugs are effective at treating a range of inflammatory diseases, some limited data suggest that they may, paradoxically, result in a higher risk of developing other de novo inflammatory conditions.
Autoimmune myasthenia gravis is typically treated with surgery, acetylcholine esterase inhibitors, corticosteroids, and immunosuppressive drugs like azathioprine and mycophenolate mofetil. Some patients have refractory disease and may require therapies like eculizumab (Soliris), which, while effective, is a particularly high-cost biologic that has no approved biosimilars in Europe or the United States, although biosimilars are advancing through clinical development. Rituximab, however, which is lower-cost than eculizumab and has multiple approved biosimilars, has also emerged as a promising treatment. 
At the United European Gastroenterology Week 2019, held in Barcelona, Spain, earlier this year, a research team from the Netherlands reported on the prevalence of patients with inflammatory bowel disease (IBD) switching back to the reference infliximab after a previous switch to biosimilar CT-P13, and found that switching back appeared to be effective in patients with IBD.
Using the same dosing as treatment for lymphoma and older age were linked with higher odds of complete remission off therapy.

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