Module 9 2024

05/09/2024

Differences EU versus US

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

Interchange-ability

No such concept

Patent dance

No such concept

Nomenclature

INN/USAN + random 4 letter suffix (IC?)

lNN – inverted black triangle indicates special ADE reporting

The Organisation for Professionals in Regulatory Affairs

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Evolving Views

2006

What constitutes a biosimilar monoclonal antibody is going to open up a completely new discussion

— Quotes from Nature Reviews Drug Discovery 5, 445 (June 2006) In my view you always need to consider them as a unique protein

2008

It remains to be seen whether the development of a biosimilar mAb is possible and feasible

— Schneider and Kalinke, Nature Biotech 09/2008

2012

As of this time, there is no MAA for a biosimilar mAb, but the stage is set — Schneider et. al, Nature Biotech 12/2012

2013

First biosimilar mAb, approved in EU!

The Organisation for Professionals in Regulatory Affairs

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