The authors report receiving writing support from Novartis Pharma AG. Cohen reports being an employee of Sandoz, a division of Novartis, as well as possible stock ownership in Novartis. Please see the study for all other authors’ relevant financial disclosures.
Although biosimilar-to-biosimilar switching is not covered by health regulations or guidance, a systematic literature review suggests the practice is safe and effective, according to data published in BioDrugs.
“As the biosimilar market continues to develop, there are often multiple biosimilars approved to a given reference biologic,” Hillel P. Cohen, PhD, of Sandoz, in Princeton, New Jersey, the lead author of the study, told Healio. “As a result, after patients transition from a reference biologic to a biosimilar, there is also a possibility that they might be subsequently switched to another biosimilar to the same reference biologic.”
“Some health care providers are hesitant to switch patients from one biosimilar to another biosimilar because of a perceived lack of clinical data on such switches,” he added.
To investigate the safety and feasibility of biosimilar-to-biosimilar switching, Cohen and colleagues conducted a systematic review. The researchers searched through December 2021 in databases including Biosis, Embase, MEDLINE and the EBM Reviews/Cochrane Database of Systematic Reviews via Ovid. A biosimilar was included in the search and analysis if itself or another biosimilar version of their common reference drug was previously approved in the United States or European Union.
Once potential studies were identified, they were individually evaluated regarding the presence of safety or effectiveness data stemming from switching biosimilars. Inclusion criteria were expansive to allow the researchers to gather as much relevant data as possible, the authors wrote. Research from non-English publications, papers detailing non-human studies, editorials, comments and brief surveys were excluded from the analysis.
The initial screening was based on title and abstracts, and included all studies mentioning biosimilar-to-biosimilar switching. The researchers then collected data from the full publications, including trial designs, patient demographics, safety results, effectiveness and immunogenicity. Additionally, the researchers evaluated the inclusion of adverse events.
In total, after further evaluation of specific papers, the authors analyzed 23 studies. Of those, 13 were published in peer-reviewed papers, and the rest were published as abstracts. The selected papers included a total of 3,657 patients. All included studies were observational. The majority of included studies examined infliximab (Remicade, Janssen) switches, but adalimumab (Humira, AbbVie), etanercept (Enbrel, Amgen) and rituximab (Rituxan, Genentech) were also regarded, the authors wrote.
Overall, published data “suggests that biosimilar-to-biosimilar switching is a safe and effective clinical practice,” Cohen and colleagues wrote.
In one analyzed study investigating swaps from infliximab to its biosimilar in patients with inflammatory bowel disease, 10.8% of patients reported a loss of effectiveness, the authors reported. A switch to the biosimilar was successful in 82% of patients with Crohn’s disease receiving adalimumab. Additionally, rituximab swaps were found to be safe and efficacious, the authors concluded.
“Rheumatologists now realize based on extensive, previously published data that patients can be transitioned from reference biologics to biosimilars without impacting safety or effectiveness,” Cohen said. “There is no scientific reason to expect that there would be clinically relevant differences if there are biosimilar-to-biosimilar switches, and this was confirmed in the results of our review.
“The results from our review reveal that rheumatologists should have confidence that the data demonstrate that safety and effectiveness are not impacted if patients switch from one biosimilar to another biosimilar of the same reference biologic,” Cohen added.