Korean drug maker Celltrion Healthcare recently presented new findings from a 2-part study at the European League Against Rheumatism European Congress of Rheumatology 2019 meeting about subcutaneous biosimilar CT-P13 (Inflectra, Remsima).
Korean drug maker Celltrion Healthcare recently presented new findings from a 2-part study at the European League Against Rheumatism European Congress of Rheumatology 2019 meeting about subcutaneous biosimilar CT-P13 (Inflectra, Remsima).
The company said subcutaneous CT-P13 may enhance treatment options for the use of biosimilar infliximab by providing high consistency in drug exposure and a convenient method of administration.
The proposed subcutaneous formulation of CT-P13 is currently under European Medicines Agency evaluation. The proposed formulation of the drug will also be studied in the United States in a phase 3 program in patients with inflammatory bowel disease.
The first part of the study investigated the pharmacokinetics, efficacy, and overall safety of CT-P13 in patients with rheumatoid arthritis during a treatment period of 1 year, as compared with the intravenous (IV) formulation of CT-P13. After enrolling 50 patients, 48 patients were randomly assigned at week 6 into 4 cohorts in a 1:1:1:1 ratio. The IV cohort received CT-P13 IV 3mg/kg every 8 weeks and the SC cohorts received CT-P13 SC 90mg, 120mg or 180mg, respectively, every 2 weeks up to week 54.
Overall, the efficacy and safety results of subcutaneous CT-P13 up to week 54 were comparable to those of the IV formulation. Disease improvement was assessed using 2 disease scores for RA, the disease activity score in a count of 28 joints with C-reactive protein (DAS28-CRP) and the American College of Rheumatology criteria for 20% improvement (ACR20) score. Results demonstrated that DAS28-CRP and ACR20 were comparable across all 4 cohorts, regardless of the route of administration or dosage of CT-P13. The safety profiles at week 6 in subcutaneous CT-P13 were comparable to CT-P13 IV and were similar to those previously reported for IV infliximab.
In the second part of the study, subcutaneous CT-P13 was shown to be noninferior in terms of efficacy and compared safety profiles compared with CT-P13 IV in people with RA over 30 weeks.
This study was followed by a phase 1/3 randomised controlled trial. A total of 362 RA patients were enrolled, of whom 348 were randomized at week 6 into 2 treatment arms in a 1:1 ratio (169 and 179 patients in SC 120mg biweekly or IV 3mg/kg arms every 8 weeks, respectively).
The trial showed that the mean change of DAS28-CRP from baseline to week 22 was similar between the 2 arms. The lower limit of the 95% CI (0.03) for the treatment difference in the change of DAS28-CRP from baseline was greater than the prespecified noninferiority margin (—0.6) indicating non-inferiority of CT-P13 SC compared to CT-P13 IV.
ACR20 responses were also similar between the 2 treatment arms up to week 22, and the safety profiles at week 6 were also comparable.
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.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.