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...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.

  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!


Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!