A study comparing generic etoricoxib (ETO) to the originator drug Arcoxia [1] finds that the generic version of the drug is bioequivalent to the reference compound, according to the Association of Southeast Asian Nation (ASEAN) bioequivalence guidelines.
ETO is a non-steroidal cyclooxygenase (COX)-2 inhibitor approved in more than 80 countries worldwide. It can be taken orally for the treatment of a range of conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and chronic and acute pain.
It shows good oral absorption, with an absolute bioavailability of 100%, and peak plasma concentration one hour after administration. It also undergoes extensive metabolism with less than 1% excreted as the parent compound in urine.
In a new study [1], researchers in Malaysia aimed to determine the bioequivalence of a generic version of ETO (120 mg, tablet formulation, Duopharma) to the innovator product, Arcoxia (120 mg, tablet formulation, Frosst Iberica).
A bioequivalence study of this type, in compliance with ASEAN guidelines, is required for a generic product to be registered under the National Pharmaceutical Regulatory Agency in Malaysia.
The randomized, open-label trial included 26 healthy male volunteers aged between 18 and 45 years. All subjects were informed about the objectives, procedures and potential risks of participation in the study and all signed an informed consent form before enrolling.
Subjects received both the test and reference products and pharmacokinetic and safety analysis was carried. Although no serious adverse events (SAEs) were reported, two adverse events (AEs) were reported, including fever and headache after administration of the reference product, and fever after administration of the test product. Both AEs were categorized as mild and no clinical biochemistry values or vital signs met the predefined criteria of clinical importance.
Pharmacokinetic parameters were also assessed, based on plasma concentrations of ETO, and fell within an acceptable range for bioequivalence according to ASEAN guidelines.
Although the study has some limitations (such as only including male participants), on the basis of their findings, the authors were still able to conclude that the generic etoricoxib 120 mg tablet (manufactured by Duopharma) meets ASEAN guidelines for bioequivalence.
Conflict of interest
This work [1] was financially supported by the Duopharma R&D fund.
Editor’s comment
Readers interested to learn more about generic drugs are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
Reasons for patients’ generic drug switching at the pharmacy counter: a pilot study
An IPRP survey of the regulatory requirements for the waiver of in vivo bioequivalence studies of generic medicinal products in certain dosage forms
How does generic drug policy affect market prices?
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Reference
1. Harikrishnan et al. Pharmacokinetics and bioequivalence of generic etoricoxib in healthy volunteers. Generics and Biosimilars Initiative Journal (GaBI Journal). 2021;10(3):113-8
DOI: 10.5639/gabij.2021.1003.013
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