Researchers at the 2023 American Academy of Dermatology Association Annual Meeting discussed the effects of product complexity on preclinical testing, among other topics.
Research has shown that biosimilars are highly similar to their originator product in terms of safety and efficacy. Two posters presented at the 2023 American Academy of Dermatology (AAD) Association Annual Meeting evaluated misconceptions about biosimilars in the dermatology community and addressed concerns around their use in psoriasis with a review of the data.
The ﬁrst poster reviewed the bio-similar approval process to clarify dermatologists’ misconceptions about biosimilars.1 “Dermatologists have approached biosimilar medicines with caution,” the researchers wrote.
A recent Cardinal Health report2 corroborated the sentiment that dermatologists are hesitant to switch to biosimilars. According to the report, only 31% of dermatologists considered themselves very familiar with biosimilars compared with 81% of gastroenterologists, 76% of rheumatologists, and 33% of ophthalmologists.
The authors of the AAD poster used a PubMed search to identify studies on the molecular design, pre-clinical and clinical testing requirements, and approval processes of biosimilars. They described how the complexity of biologics means that even batches of innovator biologics can vary during preclinical testing. “Biosimilars undergo strict preclinical testing and must demonstrate near-similarity to the current originator product in quality factors such as receptor binding and pharmacokinetics,” the researchers explained.
Although clinical testing is less stringent for a biosimilar compared with the originator product, the purpose of the clinical testing is to conﬁrm the safety and efficacy of the biosimilar. Then, the use of extrapolation allows for biosimilars to be approved for all indications of the originator product without further testing. As a result, the emphasis of biosimilar product testing is on preclinical rather than clinical testing, the authors noted.
“Physicians who recognize that biologics are too complex to duplicate, and who desire indication-speciﬁc clinical data on biosimilars, might be satisﬁed knowing biosimilars provide more evidence of similarity than we have for different batches of the innovator product,” they concluded. “Regulations that are more stringent for biosimilars than for different batches of innovator products may not be logical.”
In the second poster, the researchers addressed concerns about the use of biosimilars approved to treat psoriasis using extrapolated evidence from other diseases.3 They compared efficacy/effectiveness, safety, and drug survival of biosimilars to treat plaque psoriasis with originator products using data from 13 randomized controlled trials (RCTs) and 3 cohort studies. Of the RCTs, 10 were for adalimumab, 2 were etanercept, and 1 was inﬂiximab. Of the cohort studies, 1 was adalimumab, 1 was etanercept, and 1 was both etanercept and inﬂiximab.
Eleven trials compared biosimilars with the originator in patients who had never been on the originator product (initiators); 9 trials analyzed switching from the originator product to the biosimilar (switchers). The initiator trials all had similar rates of 75% improvement in the Psoriasis Area and Severity Index, as well as similar adverse events (AEs) by week 16. The switched trials also had similar out-comes by week 52.
One of the cohort studies reported more AEs among the group of adalimumab patients switching from originator to the biosimilar, although the other 2 cohort studies showed no signiﬁcant differences in safety and effectiveness. “The majority of available evidence suggests similarities between biosimilars and originators,” the researchers concluded. “Future pharmacovigilance studies are needed to evaluate the long-term, real-world use of biosimilars for psoriasis treatment.”