Newer isn’t always better.
This adage applies to many things. And the biotech and pharmaceutical industries are certainly not immune to this basic fact.
It’s why many drugs have been go-to standards for decades in the medical world.
It’s also why it may not necessarily be a good idea for all patients to switch away from biologics to the new biosimilars being offered on the market.
For people with rheumatoid arthritis (RA), there are plenty of potential treatment options. However, they also can be confusing and difficult to navigate — not to mention costly and sometimes dangerous.
Limits on Remicade biosimilar
The introduction of biosimilars into the ever-changing landscape of drug choices is generally considered to be a good thing for people suffering from rheumatoid arthritis because the drugs used to treat RA often fail after a sustained period of use.
However, recent reports have stated that the biosimilar version of Remicade approved for rheumatoid arthritis may be unsuitable for some people, particularly those who are classified as antibody-positive.
Those with an antibody-positive diagnosis should probably stick to the Remicade biologic versus the biosimilar version, known as Remsima or Inflectra. That recommendation was presented at the European League Against Rheumatism (EULAR) 2016 annual meeting.
The study looked at 250 people with rheumatoid arthritis and spondyloarthritis under a Remicade treatment regimen who were biosimilar-naïve. It also included 77 control patients.
Researchers concluded that when RA patients develop antibodies in response to the biologic drug Remicade, these antibodies could also cross-react with the biosimilar form of the drug when it is introduced. This can lead to adverse reactions or even render the treatment useless.
Thus, people who are already having success on Remicade should probably stay with it, the researchers said.
Not necessarily interchangeable
The biosimilar should be suitable for those who are not already taking Remicade.
According to a press release issued at EULAR, “While most studies show there are no significant differences in clinical response between a biosimilar and the original product, some physicians and patient advocacy groups have expressed concern about how interchangeable they really are, and whether it is safe to switch from the brand name version to the biosimilar,” said the study’s lead author, Daniel Nagore, Ph.D., of Progenika Biopharma in Spain.
He continued, “Our results have shown that all the antibodies that developed in patients being treated with Remicade cross reacted with the biosimilar. The presence of these anti-infliximab antibodies is likely to enhance clearance of the drug from the body, potentially leading to a loss of response, as well as increasing the risk of side effects. Therefore, in patients where biological infliximab is ineffective due to the presence of circulating antibodies, switching to its biosimilar will lead to the same problems.”
About 50 percent of the patients in the study were found to have a reaction to the biosimilar.
The individual decision regarding whether to stay on Remicade, or switch to a biosimilar, should be up to the patient and their rheumatologist, researchers said.