A paper published in Pharmaceutics describes development and validation of a production process for 5 mg tablets of infliximab, using biosimilar CT-P13 (Remsima, Inflectra), for the treatment of inflammatory bowel disease.
The oral delivery of biologic drugs represents an as-yet unattained goal. However, the potential benefits of oral administration of these therapies in terms of compliance, comfort, and drug storage are many, and several drug makers are pursuing the possibility: Last year, Amgen and Entera Bio announced a research collaboration into oral administration of biologics, and Protalix BioTherapeutics announced positive results from a study on oral administration of anti—tumor necrosis factor (anti-TNF) therapies.
Now, a paper published in Pharmaceutics describes development and validation of a production process for 5 mg tablets of infliximab, using biosimilar CT-P13 (Remsima, Inflectra), for the treatment of inflammatory bowel disease (IBD).
The authors of the paper hypothesized that, in IBD, targeting infliximab administration to the ileo-colonic region could be efficacious in treating local IBD inflammation.
The researchers used the biosimilar infliximab and reconstituted it into a sugar solution that, when lyophilized, yielded powder that could be further compounded and treated with a coating.
The coating technology (called ColoPulse) used on the tablets has a pH sensitive polymer; the intraluminal pH of the gastrointestinal tract rises during transit from the jejunum to the ileum, then drops in the colon, and the tablet’s coating uses this period of pH increase to disintegrate in the terminal ileum.
According to the researchers, the in vitro stability of infliximab in simulated gastrointestinal systems is “encouraging,” and analyses of infliximab content, tertiary protein structure, aggregates, and potency showed that the infliximab present in the coated tablet was stable during compounding and could bind to TNF.
Stability data showed that the preparation was stable for up to 6 months at 25°C.
The authors note that a clinical trial will be necessary to determine the such factors as the pharmacokinetics of the proposed coated tablet, as well as the potential for development of anti-drug antibodies.
Reference
Gareb B, Posthumus S, Beugeling M, et al. Towards the oral treatment of ileo-colonic inflammatory bowel disease with infliximab tablets: development and validation of the production process. Pharmaceutics. 2019;11(9):428. doi: 10.3390/pharmaceutics11090428.
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.