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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Pink Sheet reporter and editors discuss whether emotion could be removed from US FDA advisory committees, adverse events and advancing science in gene therapy development, and Capitol Hill’s interest in the ongoing user fee negotiations.
Recent adverse events are ‘speed bumps’ that need to be worked around, biologics center head Peter Marks says; Morgan Stanley’s Peter Hwang asserts high-profile safety issues have added to unpredictability of gene therapy development, dampening investor enthusiasm for the field.