Investor Presentaiton
14
Entyvio Any biosimilar that seeks to launch prior to 2032 would need to address
vedolizumab
potential infringement and/or the validity of all relevant patents
Takeda
Takeda has granted patents that cover various aspects of Entyvio, including formulation, dosing regimens and process for manufacturing.
These patents are expected to expire in 2032 in the U.S.
Potential scenario in the U.S. should patents be challenged in biosimilar litigation
2023
2024
2025
2026
2027
Clinical
development
timeline
Regulatory
Biosimilar clinical trials expected
to take 3-4+ years
review
(~1 year)
Legal
proceedings
Pre-litigation
process
2028
2029
2030
2031
2032
Entyvio is only approved in IBD
indications, for which clinical trials
are typically longer and more
challenging to complete than other
auto-immune diseases which we
have recently observed biosimilar
manufacturers target
In general, biosimilar litigation
proceedings in the U.S.
may take 3-5 years
In the U.S., the biosimilar litigation
process is triggered by FDA
acceptance of a relevant aBLA
Competitive Intelligence suggests Ph1 activity starting with biosimilar companies in China and Iran.
However, no vedolizumab biosimilar Phase 1 clinical trial starts targeting the U.S., EU, or Japan markets has been publicly disclosed so far.View entire presentation