Biosimilar Sponsors Looking To Avoid ‘Patent Dance’ Turn To Inter Partes Review
For now, PTO’s post-grant review process lets biosimilar sponsors challenge validity of reference product patents before BPCIA information-exchange provisions kick in; however, a legislative change may be on the horizon.
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Interactive chart of growing 351(k) pipeline shows that while Phase III is dominated by big players, pure-play biosimilar companies are beginning to emerge.
Advisory Committee on Immunization Practices fails to pass an interim recommendation endorsing third dose of vaccine in health care workers and others at risk of occupational or institutional exposure, with panelists raising concern that the target population was overly broad.
Cancer drug developers should come to the agency early with a package of clinical trials to support accelerated approval and confirm clinical benefit rather than with plans to sequentially conduct such studies, Oncology Center of Excellence’s Richard Pazdur says; he also suggests closer scrutiny ahead of whether postmarketing trials are being conducted with ‘due diligence.’