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.