BIOGENERICS - A FUTURE CONSIDERATION?
A huge potential exists for the development of biogeneric products or
generic versions of existing biotech drugs. Another term, follow-on protein, is
sometimes used to describe the same concept. It is estimated that biogenerics
could be available in the United States as early as 2009. Factors driving the
development of biogenerics include the growing number of products, size of the
biotech drug market, and the high cost of existing patent-protected products.
The Food and Drug Administration (FDA) has said that creating generic
versions of these drugs will be difficult due to the complexity of these
products. It will be difficult, if not impossible, to demonstrate an equivalent
chemical structure for biogenerics. However, legislation may be introduced to
develop a regulatory process (none currently exists in the United States) for
approval of this type of product.
The biotech market already contains several types of insulins, growth
hormones, and second generation products such as Aranesp and Neulasta.
Pharmacists and formulary committees in the future may need to choose between a
variety of biotech drugs produced in different cell lines with differences in
physical properties but producing essentially the same therapeutic effect.