A Randomized Phase I Pharmacokinetic Trial Comparing the Potential Biosimilar Adalimumab (Cinnora®) With the Reference Product (Humira®) in Healthy Volunteers

A Randomized Phase I Pharmacokinetic Trial Comparing the Potential Biosimilar Adalimumab (Cinnora®) With the Reference Product (Humira®) in Healthy Volunteers Publisher Pubmed

Jamshidi A¹ ; Sabzvari A² ; Anjidani N³ ; Shahpari R³ ; Badri N⁴

Show Affiliations

1. Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran
2. CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran
3. Medical Department, Orchid Pharmed Company, Tehran, Iran
4. Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran

Source: Expert Opinion on Investigational Drugs Published:2020

Abstract

Background: CinnoRA® (CinnaGen, Iran) is a biosimilar candidate for the reference adalimumab, Humira® (AbbVie, USA). This study aimed to compare the pharmacokinetics, safety, and tolerability of these products in healthy participants. Research design and methods: In this phase-I, randomized, double-blind trial, 74 healthy adult volunteers were randomized in a 1:1 ratio to receive a single 40 mg subcutaneous injection of CinnoRA® or Humira®. Serum concentrations of adalimumab were analyzed using a validated enzyme-linked immunosorbent assay and were evaluated by non‐compartmental methods. Pharmacokinetic equivalence between groups was determined using the standard equivalence margins of 0.80 to 1.25. Results: The baseline characteristics were similar between study groups. Mean values of area under the serum concentration-time curve from time zero to infinity (AUCinf) and maximum serum concentration (Cmax) were similar in study groups and the 90% confidence intervals for the geometric mean ratios of AUCinf and Cmax were within the prespecified equivalence margins. There were no deaths and the total number of treatment-related adverse events was not statistically different between groups (p-value = 0.19). Conclusions: The results clearly showed the pharmacokinetic similarity of the biosimilar adalimumab to the originator. CinnoRA® was safe and well-tolerated in healthy volunteers, with no significant differences in safety from the reference product. Trial Registration: The trial is registered at ClinicalTrials.gov (# NCT03273192). © 2020, © 2020 Informa UK Limited, trading as Taylor & Francis Group.

Style	Citing Format
MLA	Jamshidi A, et al.. "A Randomized Phase I Pharmacokinetic Trial Comparing the Potential Biosimilar Adalimumab (Cinnora®) With the Reference Product (Humira®) in Healthy Volunteers." Expert Opinion on Investigational Drugs, vol. 29, no. 3, 2020, pp. 327-331.
APA	Jamshidi A, Sabzvari A, Anjidani N, Shahpari R, Badri N (2020). A Randomized Phase I Pharmacokinetic Trial Comparing the Potential Biosimilar Adalimumab (Cinnora®) With the Reference Product (Humira®) in Healthy Volunteers. Expert Opinion on Investigational Drugs, 29(3), 327-331.
Chicago	Jamshidi A, Sabzvari A, Anjidani N, Shahpari R, Badri N. "A Randomized Phase I Pharmacokinetic Trial Comparing the Potential Biosimilar Adalimumab (Cinnora®) With the Reference Product (Humira®) in Healthy Volunteers." Expert Opinion on Investigational Drugs 29, no. 3 (2020): 327-331.
Harvard	Jamshidi A et al. (2020) 'A Randomized Phase I Pharmacokinetic Trial Comparing the Potential Biosimilar Adalimumab (Cinnora®) With the Reference Product (Humira®) in Healthy Volunteers', Expert Opinion on Investigational Drugs, 29(3), pp. 327-331.
Vancouver	Jamshidi A, Sabzvari A, Anjidani N, Shahpari R, Badri N. A Randomized Phase I Pharmacokinetic Trial Comparing the Potential Biosimilar Adalimumab (Cinnora®) With the Reference Product (Humira®) in Healthy Volunteers. Expert Opinion on Investigational Drugs. 2020;29(3):327-331.
BibTex	@article{ author = {Jamshidi A and Sabzvari A and Anjidani N and Shahpari R and Badri N}, title = {A Randomized Phase I Pharmacokinetic Trial Comparing the Potential Biosimilar Adalimumab (Cinnora®) With the Reference Product (Humira®) in Healthy Volunteers}, journal = {Expert Opinion on Investigational Drugs}, volume = {29}, number = {3}, pages = {327-331}, year = {2020} }
RIS	TY - JOUR AU - Jamshidi A AU - Sabzvari A AU - Anjidani N AU - Shahpari R AU - Badri N TI - A Randomized Phase I Pharmacokinetic Trial Comparing the Potential Biosimilar Adalimumab (Cinnora®) With the Reference Product (Humira®) in Healthy Volunteers JO - Expert Opinion on Investigational Drugs VL - 29 IS - 3 SP - 327 EP - 331 PY - 2020 ER -

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