Tuesday, June 22, 2010

Biosimilars White Paper: Panacea or Poison Pill? Making Sense of the New Biosimilars Law

I recently came across the BNA, Inc. white paper "Panacea or Poison Pill? Making Sense of the New Biosimilars Law." It takes an in-depth look at the new healthcare reform that allows the streamline development and FDA approval pathway for biosimilars.

According to the paper:

This article provides a brief overview of the history leading up to passage of the Biosimilar Act, discusses in detail both the FDA regulatory and patent litigation provisions of the act (with comparisons and contrasts to the Hatch-Waxman scheme), probes potential interpretations of key provisions, and offers practical strategic considerations both for companies seeking to pursue product approvals under the new law, and for companies whose products now may face increased competition from follow-on products.

Read the white paper here.

Share this article with your social network, just click below to share now!

No comments :

Post a Comment