Additionally, the paper reports differences in the enzyme active site based on crystallography studies. Agree with previous that immunogenicity issues have not been addressed. Company hasn't done clinical trials of sufficient size to look into this.
In today's BioWorld Today (9/21/10), there is an article talking about FDA set to hold a meeting on biosimilars probably in November. Deutsche Banks analyst is quoted:
"Many complex biologics have sugar chains that impact their efficacy and safety, and she noted that the FDA has made several statements over the years suggesting a primary concern that biosimilars have the same sugar structure for interchangeability..."
It is quite clear that Uplyso does not have same sugar structure as Cerezyme.