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Assessing switchability for biosimilar products: modelling approaches applied to children's growth
Author(s) -
Belleli Rossella,
Fisch Roland,
Renard Didier,
Woehling Heike,
Gsteiger Sandro
Publication year - 2015
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.1691
Subject(s) - biosimilar , human growth hormone , medicine , econometrics , computer science , mathematics , growth hormone , hormone
The present paper describes two statistical modelling approaches that have been developed to demonstrate switchability from the original recombinant human growth hormone (rhGH) formulation (Genotropin ® ) to a biosimilar product (Omnitrope ® ) in children suffering from growth hormone deficiency. Demonstrating switchability between rhGH products is challenging because the process of growth varies with the age of the child and across children. The first modelling approach aims at predicting individual height measured at several time‐points after switching to the biosimilar. The second modelling approach provides an estimate of the deviation from the overall growth rate after switching to the biosimilar, which can be regarded as an estimate of switchability. The results after applying these approaches to data from a randomized clinical trial are presented. The accuracy and precision of the predictions made using the first approach and the small deviation from switchability estimated with the second approach provide sufficient evidence to conclude that switching from Genotropin ® to Omnitrope ® has a very small effect on growth, which is neither statistically significant nor clinically relevant. Copyright © 2015 John Wiley & Sons, Ltd.