February 2018 saw a number of developments for biosimilars that treat inflammatory bowel disease, with new studies from around the globe adding to the body of data on these therapies.
February 2018 saw a number of developments for biosimilars that treat inflammatory bowel disease (IBD), with new studies from around the globe adding to the body of data on these therapies.
New NOR-SWITCH Data Focuses on IBD Subgroup
At the European Crohn's and Colitis Organisation (ECCO)'s 13th annual congress in Vienna, Austria, researchers presented new data on the IBD subgroup (comprising patients with Crohn disease [CD] and ulcerative colitis [UC]) of the NOR-SWITCH trial. Participants (n = 380) who completed the original 52-week noninferiority trial entered a 26-week, open-label extension trial that assessed the safety of uninterrupted treatment with biosimilar infliximab (CT-P13, sold in the United States as Inflectra and in the European Union as Remsima) through week 78 compared with switching from the reference product to the biosimilar at week 52.
The primary endpoint of the extension was overall disease worsening during follow-up; the investigators found no difference between patients who remained on CT-P13 versus those who switched from the reference product to the biosimilar, and that the exploratory subgroup analyses of patients with CD and UC showed similarity between the groups in terms of efficacy, safety, and immunogenicity.
Patients Remain Wary of Switching
Other data presented at ECCO suggest that communicating with patients about a potential switch to a biosimilar of a reference product is important to a successful nonmedical switch; even in cases in which patients have experienced a switch to a biosimilar as an uncomplicated transition of treatment, patients say that they remain concerned about their therapy being switched again, especially according to a pharmacist’s decision rather than a prescriber’s.
Biosimilar Adalimumab Increased Access, but With Limited Efficacy
Real-world data on India’s first available biosimilar adalimumab, Exemptia, in 29 patients with UC show that the biosimilar has increased access to treatment, but it had limited efficacy when used for induction of remission in patients with UC that was refractory to treatment with steroids. Furthermore, 4 patients in the study developed tuberculosis-related adverse events, suggesting that the biosimilar should be prescribed with caution in populations who may have high rates of latent tuberculosis.
Biosimilar Infliximab Could Help Control Cachexia
Investigators presented data at ECCO that suggest that CT-P13 could benefit pediatric and adolescent patients with CD who have cachexia, which manifests as malabsorption, nutritional deficiencies, osteopenia, sarcopenia, and growth failure. In an animal model, CT-P13 significantly improved cachexia, lowered mortality, tempered weight loss, and preserved appetite (as did reference adalimumab). These findings suggest that drugs targeting tumor necrosis factor should be considered for the treatment of young patients with CD who have wasting conditions.
Anti-Drug Antibodies May Help Guide Decision-Making in Loss of Response
Antibodies toward infliximab are associated with lower infliximab trough concentrations and loss of response, and while treatment intensification can be effective for some patients with CD, a recent study of 103 patients showed that 37% did not response to intensification, and patients with higher anti-drug antibody levels were less likely to achieve therapeutic drug levels. According to S. Ben-Horin, MD, these data suggest the need to identify patients who will respond to dose optimization before undertaking costly and potentially harmful intervention in those who are unlikely to respond to treatment.
Immunomodulators Help Prevent Loss of Response
Loss of response may be preventable, according to 12-month data from the PANTS study, which investigated primary nonresponse, loss of response, and adverse drug reactions to infliximab among 1601 patients with CD. The study’s researchers found that the rate of primary nonresponse among patients receiving CT-P13, reference infliximab, and reference adalimumab was similar, and was associated with older age, higher body mass index, and low drug levels. Immunogenicity was associated with nonremission for all treatment groups, but the use of immunomodulators together with the biologic therapies reduced the risk of immunogenicity.
AMCP Posters Tackle Interchangeability and Medicaid, Factors Driving Biosimilar Access
April 24th 2024Two posters from the Academy of Managed Care Pharmacy (AMCP) annual meeting explore how an interchangeable insulin glargine biosimilar plays into Medicaid budgets and the top factors driving access to biosimilars.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Biosimilars Gastroenterology Roundup for January 2024—Podcast Edition
February 4th 2024On this episode of Not So Different, we reminisce on all the major gastroenterology news from January, which brought several reports quantifying how the gastroenterology biosimilar market is progressing and marked the 1-year anniversary of adalimumab biosimilar competition in the US.
What Clinicians Need to Know About Using Biosimilars to Treat IBD
April 13th 2024A review article, intended to act as a guide for clinicians, summarizes the available infliximab and adalimumab biosimilars for treating inflammatory bowel disease (IBD) as well as others that are coming down the pipeline.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.