Declaratory Judgments Unavoidable For Biosimilar Applicants
Law360 (March 5, 2021, 4:33 PM EST) -- Since the enactment of the Biologics Price Competition and Innovation Act, debate has brewed over the type and amount of information a biosimilar applicant must disclose under its prescribed information exchange provisions.
The conventional belief was that, by partaking in the information exchange, a biosimilar applicant would be able to prolong, or avoid, a declaratory judgment action filed by the brand holder.
Recent data, however, suggests that a biosimilar applicant will inevitably face a declaratory judgment action irrespective of the amount and type of information it provides to the brand holder.
The first 10 years under the BPCIA has seen...
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