Module 9 2021

22/03/2021

SUBSTANTIVE DIFFERENCES US VS. EU REGULATIONS

US

EU

Regulations

Extensive 7311 Words in US Act

Light 375 Words in EU Directives supported by extensive guidance docs rDNA Peptide/Protein; complex carbohydrates EU is 10 years basic but new indications and paediatric development allows up to 12 years.

Biosimilar

rDNA Peptide >25 aa/Protein

Originator Exclusivity

12 yrs market exclusivity for innovator “Modification of structure” allows further 12 years provided added advantage. 1 yr market exclusivity for 1 st interchangeable biosimilar Confidential exchanges of detailed substantive patent contentions between biosimilar applicant and innovator INN/USAN + random 4 letter suffix (IC?)

Interchange- ability Patent dance

No such concept

No such concept

Nomenclature

lNN – inverted black triangle indicates special ADE reporting

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GLOBAL BIOSIMILAR DEVELOPMENT

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