Recent European studies have indicated that biosimilars are as effective as original biologics, which is good news for manufacturers eyeing the potentially lucrative US biosimilars market.
Conceived as versions of biologics drugs that can be used interchangeably with the original, the advent of biosimilars represented a breakthrough for the pharmaceutical industry, but physicians have been slow to accept their efficacy and prescribe them to patients.
This is largely down to the fact that, unlike generic drugs, biosimilars are not exact copies of the original drug on which they are modeled, leading some medical experts to raise questions about their safety and usefulness.
These fears will have been allayed somewhat by studies in Hungary, the Czech Republic and the Netherlands, which showed no significant change in bowel disease patients who switched from a biologic to an equivalent biosimilar medication.
European Studies Easing Concerns About Biosimilars
The Hungarian report, which studied 291 patients over a 54 week period, found that a biosimilar of infliximab called CTP-13 was effective in maintaining clinical remission in patients suffering from Crohn’s disease and ulcerative colitis. A similar report from the Czech Republic found that there was no increase in immunogenicity among 74 patients with irritable bowel disease who switched to CTP-13.
Finally, a third report, this time from the Netherlands, studied 78 patients and found that switching from the biologic Remicade to CTP-13 caused no significant reduction in quality of life and no adverse effects at the 16 week stage, leading researchers to conclude that switching to the biosimilar alternative was therefore feasible.
Although it is significantly more costly to produce a biosimilar drug than it is to develop a generic, these reports indicate that the future looks bright for biosimilar manufacturers. So far, Europe has led the way in the use of biosimilars, but the US Food and Drug Administration has recently recommended the approval of CTP-13 which could lead to the opening of the US market, offering dramatic scope for growth in the biosimilar industry, a process that is likely to be accelerated as further favorable reports into the efficacy of biosimilars are released.
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