Business Strategies
> Biopharmaceuticals
As Barr
evaluates new product development and new technologies to expand
its generic and proprietary operations, the Company is also
investing in the effort to open an exciting new frontier for
future growth: generic biopharmaceuticals.
The Company
is actively pursuing those business development initiatives
and internal development activities that will enable it to bring
both generic and proprietary biopharmaceutical products to market.
Barr intends to build a leadership position in the development
and marketing of such products in the future.
In
2004, biopharmaceuticals represented an industry with more than
150 biopharmaceutical products and $28 billion in annual sales.
However, the U.S. Food & Drug Administration (“FDA”)
has not recognized an abbreviated regulatory pathway for the
timely and cost-efficient approval of generic versions of these
products, many of which have lost patent protection or will
lose patent protection within the next several years.
To support
efforts in this area, Barr is actively pursuing the identification
of sources for biopharmaceutical active ingredients, as well
as exploring potential partnerships and product acquisitions
to bring generic biopharmaceuticals to market. An example of
this partnering strategy is the March 2005 agreement with PLIVA
to develop and market a generic version of G-CSF in the United
States and Canada.
Barr is
working with Congress, the Department of Health and Human Services
(“HHS”), including the FDA, and the Generic Pharmaceutical
Association (“GPhA”), to help define the regulatory
pathway for approval of generic versions of biopharmaceutical
products.
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