Biologics and Biosimilars

By Kate Greenwood
In Biologics and Biosimilars
Nov 17th, 2014
0 Comments
By Jordan Paradise The Biosimilars Price Competition and Innovation Act of 2009 (BPCIA) introduced a long-awaited, and highly-supported, abbreviated route to market for “biosimilar” and “interchangeable” biologic products. The goal was to create incentives for development and reduce health care costs in the same way that previous legislation had accomplished in the gen...
By Jordan Paradise
In Biologics and Biosimilars
Mar 19th, 2014
0 Comments
While the Food and Drug Administration (FDA) and the Federal Trade Commission contemplate the wide-ranging implications of recent legislation creating an abbreviated approval process for biologic products, states are busy tackling issues of pharmacist substitution.  The current implementation debate at the federal level focuses chiefly on the scope of scientific and te...
By Jordan Paradise
In Biologics and Biosimilars
Jun 13th, 2011
0 Comments
FDA Taking Baby Steps towards Regulating Nanotechnology Jordan Paradise, J.D.[1] [Ed. Note: HRW is pleased to welcome Seton Hall Law Professor Jordan Paradise, who researches and publishes on the legal, ethical, and societal implications of emerging science and technologies such as genetics and nanotechnology. She teaches Food & Drug Law, Administrative Law and Adv...
By Kate Greenwood
In Biologics and Biosimilars
Dec 15th, 2010
2 Comments
Yesterday, I got a note from my son’s kindergarten teacher alerting me that the class had run out of hand sanitizer and tissues and needed donations to replenish their supply.  Proof positive that cold and flu season is upon us. Less commonly known is that, in most or all of the country, it is also […]...
By Valerie Gutmann
In Biologics and Biosimilars
Oct 7th, 2009
3 Comments
Two months ago, I discussed possible federal legislation intended to balance the competing need for scientific and medical innovation with the costs to patients for biosimilars.  So where does the debate stand now? Current proposals couple a regulatory approval pathway for biosimilars with exclusivity periods for pioneer biologics.  As part of its July 15, 2009 [&helli...