Pharmacokinetic bioequivalence found between biosimilar, etanercept

GP2015, a proposed etanercept biosimilar, showed pharmacokinetic bioequivalence with etanercept in healthy patients, according to results presented at the EULAR Annual Congress.

Researchers randomly assigned 54 healthy male patients to a single 50-mg subcutaneous injection of GP2015 (Sandoz) or etanercept (Enbrel, Amgen), followed by a washout period of at least 35 days and a single 50-mg subcutaneous injection of etanercept or GP2015. According to the researchers, bioequivalence between GP2015 and etanercept for primary pharmacokinetics parameters was present if 90% CIs for the ratio of geometric means were completely contained within the predefined bioequivalence limits of 0.8 to 1.25.

Results showed the 90% CIs were within the interval of 0.8 to 1.25 for the ratios of geometric means of dose normalized primary pharmacokinetics parameters and for the respective nominal dose primary pharmacokinetics parameters. Researchers found neutropenia, headache and nasopharyngitis were the most common adverse events regardless of relationship to study drug, with all treatment-related adverse events of mild or moderate intensity. According to results, no patients experienced serious adverse events or death during the study. At the 28-day follow-up visit, researchers noted three patients had low titer and non-neutralizing antidrug antibodies. – by Casey Tingle

Reference:

Afonso M, et al. Abstract #THU0145. Presented at: EULAR Annual Congress; June 8-11, 2016; London.

Disclosure: All of the researchers are employees of Hexal AG, an affiliate of Novartis.