Biosimilars 101

To access a recording of this webinar or receive a copy of the slides, please contact [email protected].

This year the FDA approved the first biosimilar drug under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and the courts have recently rendered some important statutory interpretations. This represents the dawn of a new era in the approval and marketing of biologic products. Join Fish attorneys for a four-part webinar series designed to help you navigate the yet unsettled waters of products.

The series will cover the regulatory framework governing biologics and biosimilars; differences between the BPCIA and Hatch-Waxman in terms of patent protection and litigation; recent BPCIA court cases; and IPR activities related to biologics.

In the first webinar of the series, join Fish principals Terry Mahn and Chad Shear as they discuss:

• Rules and regulations governing biologics
• The similarities and differences between biosimilars, interchangeables, and generic drugs
• What pioneers and biosimilars should be doing now

This series will prove valuable for those already familiar with the BPCIA as well as for those just starting to grapple with its provisions.