The study sought to assess the efficacy, tolerability, and safety of CT-P13 versus its reference and versus adalimumab in patients with Crohn disease (CD).
Anti—tumor necrosis factor (anti-TNF) agents are an important therapy for patients with Crohn disease (CD), but given the cost of anti-TNFs, use of these agents to treat some European patients with inflammatory bowel disease has been limited. A recent study from Poland—one such nation where patients have historically had limited access to biologics but where access has increased with the introduction of biosimilars—showed that the cost-saving biosimilar infliximab CT-P13 (Inflectra, Remsima) had comparable safety and efficacy to both its reference and to adalimumab in patients with CD.
The retrospective, single-center study included a cohort of 286 Polish patients with CD. The study sought to assess the efficacy, tolerability, and safety of the biosimilar versus its reference and versus adalimumab. Patients had moderate or severe CD and an insufficient response to standard therapy. Patients were assigned to receive reference infliximab (n = 82), the biosimilar (n = 109), or adalimumab (n = 95); patients treated prior to 2014 received the reference, and those treated after, due to a change in hospital funding, were given either adalimumab or the biosimilar based on their previous treatment (more than 30% of patients had received prior anti-TNF therapy) and on patient preference.
At 12 months, there were no statistically significant differences among the reference infliximab, biosimilar, and adalimumab groups, respectively, on the following criteria:
There was a similar relapse rate between patients receiving the biosimilar (54%) and adalimumab (61%), but more patients who received reference infliximab (83%) experienced relapses during 1 year of observation, and this difference reached statistical significance (P <.001).
Adverse events (AEs) were reported in 15% of the reference group, 17% of the biosimilar group, and 9% of the adalimumab group. The most commonly reported AEs were skin reactions.
According to the authors, this study has demonstrated the safety and efficacy of the biosimilar in comparison with both its reference and with adalimumab, not only with induction, but also during 1 year of therapy, and relapse rates were lower with the biosimilar than with the reference infliximab.
Reference
Kaniewska M, Rosolowski M, Rydzewska G. The efficacy, tolerability and safety of infliximab biosimilar in comparison to originator biologic and adalimumab in patients with Crohn’s disease [published online July 17, 2019]. Pol Arch Intern Med. doi: 10.20452/pamw.14901.
Spanish Real-World Study: Adalimumab Biosimilar MSB11022 Safe, Effective in IBD
May 18th 2024A real-world study in Spain on inflammatory bowel disease (IBD) patients found no meaningful changes in clinical or biochemical markers or differences in effectiveness between the adalimumab originator and the biosimilar MSB11022 (Idacio; Fresenius Kabi) in adalimumab-naïve patients.
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.
Patients With IBD Experience Nocebo Effect Post Mandatory Switch to Biosimilar
May 11th 2024In Canada, a study on patients with inflammatory bowel disease (IBD) switching to infliximab or adalimumab biosimilars found no change in clinical remission or antidrug antibodies after 24 weeks, but 13% experienced the nocebo effect, leading to one-fifth discontinuing therapy.
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.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.