Pharmacokinetic and safety analysis of biosimilar adalimumab in healthy volunteers in Bangladesh

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2024年2月28日

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Umme Kulsum,
Kasrina Azad,
Mubasshir Washif,
Mohabbat Hossain,
Nishat Sultana,
Ismail Hossain,
Faez Ahmed,
Ridwanur Rahman,
Abdul Muktadir,
Hasneen Muktadir,
Mahbubul Karim,
Mohammad Mizanur Rahman,
Md Shawkat Hossain,
Syed Abdul Monim,
Alex S. Pandey,
Firdausi Qadri,
Zannat Kawser

摘要

Aims

Advixa is a monoclonal antibody manufactured as a biosimilar to adalimumab (Humira, Abbvie Inc.). The key objectives of this study were to use a healthy population group to assess pharmacokinetics (PK) and safety similarity between Advixa and Humira in healthy participants and to quantify the effects on adalimumab PK and safety to assess the impact of treatment with Advixa.

Methods

A group of healthy participants selected by screening aged between 18 and 45 years. According to the randomization table, each participant was given Adalimumab (Advixa or Humira) in the inpatient facilities in a hospital and observed for 72 h. Several blood samples were collected from the participants at different time points up to day 64 to measure their Pharmacokinetics and biosimilarity. The study was registered at clinicaltrial.gov retrospectively.

Results

The serum concentration–time profiles for PK and safety were compared in this randomized, double-blinded study between Humira and Advixa. A review of the data for biosimilarity confirmed that these products are similar to each other regarding healthy participants. 90% confidence interval of the relative mean C_max, AUC_0-t, and AUC_o-inf of the Advixa and Humira were found within the acceptance criteria. No differences in safety profiles were observed in these studies.

Conclusion

PK and safety are similar between Advixa and Humira in participants with healthy status demonstrated in this clinical trial (NCT05172817; Registration Date/Initial Release Date: 28/09/2021). Adalimumab PK was also similar to treatment with Humira and Advixa.