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GP2017, an adalimumab biosimilar: pharmacokinetic similarity to its reference medicine and pharmacokinetics comparison of different administration methods.
von Richter O, Lemke L, Haliduola H, Fuhr R, Koernicke T, Schuck E, Velinova M, Skerjanec A, Poetzl J, Jauch-Lembach J. von Richter O, et al. Among authors: skerjanec a. Expert Opin Biol Ther. 2019 Oct;19(10):1075-1083. doi: 10.1080/14712598.2019.1571580. Epub 2019 Jan 30. Expert Opin Biol Ther. 2019. PMID: 30698045 Clinical Trial.
GP2015, a proposed etanercept biosimilar: Pharmacokinetic similarity to its reference product and comparison of its autoinjector device with prefilled syringes.
von Richter O, Skerjanec A, Afonso M, Sanguino Heinrich S, Poetzl J, Woehling H, Velinova M, Koch A, Kollins D, Macke L, Wuerth G. von Richter O, et al. Among authors: skerjanec a. Br J Clin Pharmacol. 2017 Apr;83(4):732-741. doi: 10.1111/bcp.13170. Epub 2016 Dec 16. Br J Clin Pharmacol. 2017. PMID: 27790726 Free PMC article. Clinical Trial.
Differences in immunogenicity associated with non-product related variability: insights from two pharmacokinetic studies using GP2017, an adalimumab biosimilar.
von Richter O, Lemke L, Haliduola H, Balfour A, Zehnpfennig B, Skerjanec A, Jauch-Lembach J. von Richter O, et al. Among authors: skerjanec a. Expert Opin Biol Ther. 2019 Oct;19(10):1057-1064. doi: 10.1080/14712598.2019.1603959. Epub 2019 Apr 19. Expert Opin Biol Ther. 2019. PMID: 31002537 Clinical Trial.
A large multicentre, randomized, double-blind, cross-over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US- and EU-reference biologics.
Bellon A, Wang J, Skerjanec A, Velinova M, Dickerson D, Sabet A, Ngo L, O'Reilly T, Tomek C, Schussler S, Schier-Mumzhiu S, Gattu S, Koch SD, Schelcher C, Dobreva M, Boldea A, Nakov R, Otto GP. Bellon A, et al. Among authors: skerjanec a. Br J Clin Pharmacol. 2020 Jun;86(6):1139-1149. doi: 10.1111/bcp.14226. Epub 2020 Feb 21. Br J Clin Pharmacol. 2020. PMID: 32022282 Free PMC article. Clinical Trial.
38 results