BIOPHARMA:  Biopharmaceutical Products in the U.S. and European Markets

New:  Biosimilars/Biobetters Pipeline Database

Products Database
  All Fields 

- Retrieve all products
Indexing fields
  Products/Active Agents 
Companies Involved 
Product Class 
Revenue/Year* ($million)  gte (from) lte (to)
(use both fields for ranging; no '$' or comma)
Marketing Status  US
Approval Status  US
FDA Approval Year**  from (≥) thru (≤)
(for a single year, enter year in both fields)
EU Approval Year from (≥) thru (≤)
(for a single year, enter year in both fields)
FDA Approval Type 
Chemicals (non-active) 
Monograph no. search   

Biosimilars/Biobetters Module (for subscribers)
  US Patents Expiration ends ≤
  US Data Exclusivity Exp. ends ≤
  US Orphan Exclusivity Exp. ends ≤
  US Biosimilars Launchabilty1  starts ≥
  US Biobetters Launchabilty1  starts ≥
  EU Patents Expiration ends ≤
  EU Data Exclusivity Exp. ends ≤
  EU Orphan Exclusivity Exp. ends ≤
  EU Biosimilars Launchabilty1  starts ≥
  EU Biobetters Launchabilty starts ≥
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 products 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.

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