In recent years, we have seen biosimilars appear on the pharmaceutical scene. A biosimilar is a biologic that is almost the same as another approved biological medication. In fact, in the EU biosimilars are prescribed with the same safety and effectiveness of traditional biologics. In a year-long recent U.K. study researchers compared the effectiveness of Humira versus it’s biosimilar SB5 in IBD patients. Their findings were quite surprising and they even measured both those that switched from Humira to SB5, and those who started SB5 without having Humira previously.
After a year, both the patients that switched and that started the biosimilar SB5 saw no difference in drug persistence, C-reactive protein, clinical remission, and calprotectin levels. This is quite an amazing find! Humira, a TNF monoclonal antibody, has been shown to be effective in moderate to severe Crohn’s and Colitis, but can be quite expensive with the average therapy costing over $5,000 here in the US. The goal of creating the biosimilar is to provide the same care at a better cost. SB5, or Hadlima, was approved for use in the EU in 2017, but the US has yet to look at this medication. However, it is scheduled to be available to Americans in 2023.Â
In this recent study, all participants were adults with IBD, and of the 481 participants 80% had Crohn’s. Patients were put into groups based on when and if Humira treatment started. 256 switched from Humira to SB5, and the other 225 started taking SB5. These treatments were injections given at 40mg every other week. After a year’s follow up, the biosimilars persistence was 62.5% in the switch group, and 83.1% in the start group respectively. Trough levels were also steady with detectable antibodies in 10.5% of the switch group, and 22% in the start group. On average, patients were able to take SB5 for 32.5 months before having to switch.    Â
Approximately 35% of those who took SB5, had to stop due to reactions or loss of effectiveness. However, if willing they were then switched to another biosimilar APB 501, also known as Amjevita, Amgevita, or Solymbic. A pretty remarkable thing happened after switching patients; none of them needed to make dosage changes or discontinue the drug during this study’s follow-up of 32 weeks. This is the first study to be conducted that allowed for two biosimilars back-to-back. This shows that even though medical professionals were weary to switch from one biosimilar to another, it seemingly can be done and done effectively.
The results of this study are quite encouraging, as many who take biologics will end up having to switch to a different one because of loss of effectiveness. These new biosimilars not only could provide financial relief, but bring more options for medication before surgery is needed. In the IBD world these biosimilars could mean more clinical remission, less surgery, and major savings. The same group of researchers that conducted this biosimilar study are set to do another one soon focusing on infliximab (Remicade). This study will pave the way for more biosimilar research abroad and in the US, bringing hope for the future to many IBD and autoimmune patients.     Â
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