Abstract
Abstract
Context: In the US, the trade-off between incentivizing innovation and providing affordable medicines is managed by government regulation. New medicines are provided a lucrative period of exclusivity that is followed by competitive entry and lower prices. For small-molecule drugs, generic competition is now common, whereas for most biologics, biosimilars are unavailable, and the regulations governing competition are relatively new.
Methods: The authors compared the nominal patent term (time between originator/brand entry and the latest patent expiration date) and effective market life (time between originator/brand entry and biosimilar/generic entry) of the 15 biologics and 141 small molecules experiencing competitive entry during 2015–25. They also examined how litigation outcomes affected these outcomes.
Findings: Despite having a much longer nominal patent term, the effective market life of biologics was similar to small-molecule drugs in recent years. Biosimilars were more likely to be launched during active patent litigation, whereas generics were more likely to be launched after settlements.
Conclusions: Although biosimilars are still relatively rare, the patent litigation structure does not appear to be slowing competitive entry for biologics relative to small-molecule drugs. Biosimilar competition may become more common as biologics advance in their life cycle and regulations are brought to bear.