The potential for a biosimilar class of drugs came into existence via the Biologics Price
Competition and Innovation Act (BPCIA) of 2009, itself a part of the Patient Protection and …

To improve access to biologic drugs, Congress authorized the FDA to create an abbreviated
pathway for approving biologics that are “biosimilar” to approved products. Reconciling the …

REPORT own versions of these biologics, which have been described as “follow-on
biologics” or “biosimilars.” In the United States and the European Union, biosimilar is a …

In March 2010 Congress established an abbreviated Food and Drug Administration
approval pathway for biosimilars—drugs that are very similar but not identical to a reference …

With the passing and implementation of the Biologics Price Competition and Innovation Act
in 2010, biosimilars became a new classification of FDA-approved drugs. The biosimilar …

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an
abbreviated licensure pathway in the United States that allows for the development and …

Recently, several physicians and health policy analysts took to the Health Affairs blog to
propose what was, to anyone who has been following biosimilars for the last decade or …

Ever since the signing of the US healthcare reform legislation, the Patient Protection and
Affordable Care Act (PPAC), speculation as to what a US FDA biosimilar programme might …

Abstract The Biologics Price Competition and Innovation Act (BPCIA), enacted as part of the
2010 Patient Protection and Affordable Care Act (ACA), authorized the US Food and Drug …

In March 2010, the US passed the healthcare reform bill, including The Biologics Price
Competition and Innovation Act of 2009, which established an abbreviated Biologic License …