Investigation of the Physicochemical and Biological Stability of the Adalimumab Biosimilar CT-P17.

Adv Ther

Faculty of Pharmacy, French Academy of Pharmacy, 4, Avenue de l'Observatoire, 75004, Paris, France.

Published: November 2021

AI Article Synopsis

  • CT-P17 is a newly approved biosimilar of adalimumab (Humira) by Celltrion, and it has been evaluated for stability under various storage conditions.* -
  • The study compared CT-P17's stability to that of reference adalimumab and other biosimilars (ABP 501 and SB5) under low and room temperature settings over 28 days, finding that all maintained quality.* -
  • Results indicate CT-P17’s stability is not significantly affected by temperature, protein concentration, or delivery device, making it suitable for storage for up to 28 days at room temperature with 60% humidity.*

Article Abstract

Introduction: CT-P17 (Celltrion, Inc., Incheon, Republic of Korea) is a biosimilar of reference adalimumab (Humira; AbbVie Inc., North Chicago, IL, USA), which has recently received regulatory approval from the European Medicines Agency.

Methods: This analysis was designed to evaluate the stability profile of CT-P17 compared with reference adalimumab and the currently licensed adalimumab biosimilars ABP 501 (Amjevita/Amgevita; Amgen Inc., Thousand Oaks, CA, USA) and SB5 (Imraldi; Biogen Inc., Cambridge, MA, USA) when stored at low temperature (5 °C) or room temperature (25 °C) with 60% relative humidity for up to 28 days.

Results: Multiple orthogonal and complementary tests demonstrated that CT-P17 was stable for 28 days under all tested conditions, as well as for protein concentrations tested (50 vs 100 mg/mL), type of delivery device (autoinjector vs prefilled syringe), and manufacturing date (recently manufactured vs aged for 17 months). There were slight differences among products in terms of charge variants, oxidation level, purity, and number of subvisible particles; however, overall, the quality of each product was maintained over 28 days.

Conclusion: Our data suggest that CT-P17 may be used without any significant loss of stability when stored at 5 °C or 25 °C with 60% relative humidity for up to 28 days, and was not impacted by protein concentration tested and delivery device. Comparative stability data suggest that the appropriate maximum storage period for CT-P17 may be up to 28 days at room temperature with 60% relative humidity.

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Source
http://dx.doi.org/10.1007/s12325-021-01929-xDOI Listing

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