Business Strategies
> Generic Biologics
An emerging opportunity
for Barr is the development and marketing of generic biologics. As a result of
the 2006 PLIVA acquisition, the Company significantly expanded its presence in
generic biologic product development and enhanced its ability to produce such
products for various global markets.
In addition, the Company
is actively pursuing business development initiatives and international development
activities to strengthen its ability to bring generic biologics products to market.
Barr intends to build a future leadership position in the development and marketing
of such products.
Sales of biologic medicines are growing exponentially. U.S. spending on biologics
increased 127% from 2001 to 2005. In 2006, biologic sales increased 20% to $40.3
billion, compared to 8% sales growth for traditional drugs. Eighteen of the 101
drugs that generated more than $1 billion in worldwide sales in 2006 were biologics.
Many of these products are no longer patent protected, or will lose patent protection
within the next few years. However, unlike in the European Union (EU) where an approval
mechanism for generic biologics exists, the U.S. Food and Drug Administration (FDA) has
not recognized an abbreviated regulatory pathway for timely and cost-efficient approval
of generic versions of these products.
To overcome this U.S. approval barrier,
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 these products in the United States, which represents the largest
potential market. It is also working in various European markets to develop products that
meet evolving EU regulatory standards.
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