Abstract
EXECUTIVE SUMMARY
The first generation of biopharmaceuticals manufactured using recombinant
technologies was launched in the 1980s, and patents protecting them are now
nearing expiration. As with small molecule drugs, the expiration of patents
creates an opportunity for generic biologicals to enter the market. Due to the
complexity of biological drugs, such products are usually referred to as
‘biosimilars' or ‘follow-on biologics' , although the term
‘biogenerics' may be applied to simple peptides.
Despite delays by the US FDA, and opposition from originator companies,
biosimilars now represent one of the most rapidly evolving areas of product
development in the pharmaceutical industry. The EU already has legislation in
place for the approval of biosimilars, and the US is set to follow suit
following the passing of landmark legislation by the US Senate Health
Committee in June 2007. In the same month another significant milestone in the
development of biosimilars was reached when the EMEA recommended three
biosimilar versions of recombinant erythropoietin (EPO), a complex
glycoprotein, for approval.
As discussed in this Report, companies active in the biosimilars sector are
currently targeting products which are now off-patent in Europe: in particular
human growth hormone (hGH), EPO and granulocyte colonystimulating factor
(G-CSF). However, there are many more potential targets for development in
areas, which have so far attracted fewer developers in the Western markets.
This Report focuses on 59 protein and 14 peptide therapeutics, which achieved
high-volume global sales in 2006. Half of the protein products generated sales
in excess of $500 million. We analyse these potential targets in the context
of other commercial products based on the same active ingredient which are on
the market or in development worldwide. This information, derived from the
Pharmaprojects database, will provide the reader with a snapshot of the
commercial landscape relevant to each target product, and highlight related or
improved products which may themselves become targets for biosimilar
development.
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