Accelerating Biosimilar Market Access
Author Information
Author(s): Tu S Sean, Goode Rachel, Turner Matthew, Van de Wiele Victor
Primary Institution: West Virginia University College of Law
Hypothesis
Can allowing biosimilar manufacturers to initiate patent litigation earlier reduce market entry delays?
Conclusion
Allowing biosimilars to start patent litigation at the beginning of phase 3 clinical trials could reduce market entry delays by about 1.8 years.
Supporting Evidence
- 92% of biosimilars that started phase 3 trials submitted their application to the FDA.
- Only 8% of biosimilars failed to obtain FDA approval after initiating phase 3 studies.
- 75% of biosimilars settle their patent litigation cases before a final judgment.
Takeaway
This study suggests that if companies making cheaper versions of biologic drugs can start legal battles earlier, they can get their products to market faster.
Methodology
The study analyzed patent litigation data and clinical trial outcomes for biosimilars from 2010 to 2022.
Limitations
The study may overcount failed trials due to incomplete reporting and is limited to trials conducted in the US.
Digital Object Identifier (DOI)
Want to read the original?
Access the complete publication on the publisher's website