Page 28 - PRECONGRESS COURSE 06

Differences in Bioactivity of different r-FSH preparations
(Olsson et al., J Clin Pharmavology 2014)
Daily injections of 225 IU
Key Points 2
Single injection of 225 IU i.v. followed by a single injection of 425 IU s.c.
 Urinary preparations are generally more acidic compared to rec FSH preparations
 Urinary preparations are the most acidic ones followed by highly purified preparations whereas the
recombinant preparations are the least sialylated
 Within the recombinant families the extent of sialylation also differs however to a lesser degree compared to urinary preparations
 Similarly the complexity determined by the degree of sialylation of the Asn bound oligosaccharides also differs considerably between rec FSH preparations
 Recombinant FSH is either derived form transfected animal cells or from transfected human cell lines
 Recently a number of biosimilars have been approved by the FDA and biosimilars are flooding the
market nowadays and do also differ in composition and acidity
 All these factors might at the end of the day impact on the clinical efficacy of different preparations
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