After years of legislative roadblocks and slow delivery of regulatory guidance, the world’s largest biologics market, the United States, is finally open for business to biosimilars with the entry of Zarxio and the most recent approval of Inflectra.

With the arrival of biosimilars in the US market, preliminary questions and uncertainties have become clearer. However, critical open questions remain unanswered for biopharmaceutical manufacturers.

Critical Question 1: How should biosimilars-related legislation be interpreted and what is the impact of such legislation to product commercialization?

Initial Learning: Biosimilars sponsors are not required to disclose their biosimilar dossier but they must provide reference brand companies with 180 days’ notice of marketing after FDA approval.

Sandoz’s experience as the first user of the US biosimilars approval pathway has forced the courts to clarify how to interpret the Biologics Price, Competition and Innovation Act (BPCI Act) that established the pathway.


The biosimilar applicants Apotex, Pfizer, and Celltrion all argue that they are exempt from providing the reference product sponsor with marketing notice because they participated in the information-sharing components of the biosimilars pathway, unlike Sandoz.

In recent court rulings in the case of Apotex, The District Court of Florida and the Federal appeals court have both ruled that the 180 days’ notification is mandatory, irrespective of whether the information-sharing steps have been adhered to. With the Apotex case recently settled, it is now clear that irrespective of whether a company follows the information-sharing process or not, there will be a delay between FDA approval and launch of at least 180 days.

Unanswered Questions: Will current interpretation of the BPCIA be altered by future court rulings?

Currently open cases initiated by Amgen and Sandoz are both seeking a review of the Federal Circuit decision on the Zarxio case, which has been referred to the Supreme Court. This could result in many more months of debate about what the statute was intended to achieve. Furthermore, new lawsuits may be filed in future that challenge different clauses of the BPCIA. As a consequence, some uncertainty regarding the biosimilars pathway persists.

More detail on our thoughts regarding initial learnings related to this question, are available in our full Executive Briefing. Click here to download.

Additionally, our full Executive Briefing includes key facts and findings about the first US Biosimilar, supported by our Real World Evidence data assets, as well as expert insights on the following additional critical questions:

  • What are the implications of FDA naming and labeling guidelines for biosimilars?
  • How will physicians adopt biosimilars into clinical practice, if at all?
  • What are the market access and distribution implications for biosimilars?

These market insights are supported by DRG Real World Evidence! Learn more about DRG RWE here.

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