Biosimilars in the United States: Unraveling the Path Forward and Lessons Learned from Europe (Part II)
As we continue our multi-part series on Biosimilars, Sapna Palla, Partner, and Monica Kolinsky, Associate, in the Life Sciences Group will address the rapid development of Biosimilars and the immense economic opportunities for companies who can successfully get approvals for their biosimilar products. While the United States is still coming to grips with its recently established biosimilars regime, Europe is ahead of the game with a much more established regime.
In this second part of our Biosimilars series, Sapna Palla and Monica Kolinsky will discuss:
The implications of the Amgen v. Sandoz Supreme Court Decision
Federal Pre-emption under the Biologics Price Competition and Innovation ACT ("BPCIA")
Discovery under the BPCIA and practical considerations to address discovery loopholes
Update on differences compared to the European regime and lessons learned.
Practical tips and considerations for companies in the Biosimilars space operating both in the United States and internationally.
- FSMA Update: FDA Issues Final Q&A Guidance on Food Facility Registration and a New Supplemental Draft Guidance on Registration Requirements for Multiple Entities Using a Shared Space
- DEA Proposes Reduction in US Opioid Manufacturing Quotes
- EC JRC Publishes Report on Mapping Nanomedicine Terminology in Regulatory Landscape