What types of related entities should be ineligible for a 12 exclusivity for a subsequent BLA?
What type of modification to the structure of a product that results in a change in safety, purity, or potency, such that a subsequent BLA may be eligible for a 2 nd 12-year period of market exclusivity?
type and quantity must comply with relevant criteria
and related detailed Guidelines
results of other tests and trials from the reference medicinal product's dossier shall not be provided
EU product specific guidelines EMEA/CHMP/BMWP/102046/2006 Draft guideline on similar rIFNa EMEA/CHMP/BMWP/496286/06 Concept Paper On Similar Low Molecular Weight Heparins - (Non) Clinical Issues July 06 EMEA/CHMP/94526/05 similar rEPOs June 06 EMEA/CHMP/94528/05 biosimilar somatropin June 06 EMEA/CHMP/32775/05 biosimilar rhInsulin June 05 CHMP/31329/05 biosimilar rGC-SF