EU Biosimilars Launchabilty 1
EU Biobetters Launchabilty 2
Caution, retrieving and determining relevance of patents is difficult and subjective! More in-depth
searching and analysis are recommended before
relying on these data for business-related decisions.
1Biosimilarity launchability = the latest date of patent and data and market exclusivities expirations.
2Biobetters launchability = the patents expiration date. With biobetters being new, different products, data and market exclusivities
do not apply.
3Patent expirations - U.S. patent extensions included, but not EU SPCs (which are country-specific).
4Data exclusivity exp. = provided for essentially all approved products, not just the ~150
with biosimilars-related patent and exclusivity data;
12 years from BLA approval in U.S.; 10 years from MAA approval in EU; EU 1 year additions for supplemental
approvals of significant new indications not included
5Market exclusivity = provided for all approvals, but you need to check whether product
actually received any orphan approvals;
orphan exclusivity (7 years U.S.; 10 years for EU); Note, pediatric indications-based extensions not included.