Manufacturing of Recombinant Human Follicle-Stimulating Hormone Ovaleap® (XM17), Comparability with Gonal-f®, and Performance/Consistency-Reference-Cited by-同舟云学术

Manufacturing of Recombinant Human Follicle-Stimulating Hormone Ovaleap® (XM17), Comparability with Gonal-f®, and Performance/Consistency

Published:2017-04-06 Issue:2 Volume:17 Page:305-312
ISSN:1174-5886
Container-title:Drugs in R&D
language:en
Short-container-title:Drugs R D

Author:

Winstel Rainer,Wieland Juergen,Gertz Beate,Mueller Arnd,Allgaier Hermann

Funder

BioGeneriX AG, a member of the Teva group

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology

Link

http://link.springer.com/content/pdf/10.1007/s40268-017-0182-z.pdf

Reference13 articles.

1. European Medicines Agency. Ovaleap (follitropin alfa) [assessment report]. 31 July 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002608/WC500152908.pdf . Accessed 16 Dec 2016.

2. Andersen CY, Westergaard LG, van Wely M. FSH isoform composition of commercial gonadotrophin preparations: a neglected aspect? Reprod Biomed Online. 2004;9:231–6.

3. Wurm FM. Production of recombinant protein therapeutics in cultivated mammalian cells. Nat Biotechnol. 2004;22:1393–8.

4. European Medicines Agency. Guideline on similar biological medicinal products. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf . Accessed 16 Dec 2016.

5. Lammerich A, Mueller A, Bias P, Phase I. two-way, crossover study to demonstrate bioequivalence and to compare safety and tolerability of single-dose XM17 vs Gonal-f® in healthy women after follicle-stimulating hormone downregulation. Reprod Biol Endocrinol. 2015;13:130.

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