One of the biggest issues facing biogeneric products is the question of how to show bioequivalence. It is imperative to be able to show that two active ingredients are identical, this is difficult because biotechnology products tend to be complex in structure, heterogeneous, and produced by fermentation of living organisms. In addition, they typically have poorly understood structure, function, and clinical efficacy.
Another challenge that has emerged is whether there is sufficient availability of bulk material and bulk biogeneric suppliers. Several reliable contract biopharmaceutical producers are emerging; however, their focus has been mainly on exclusive custom manufacturing of new biologicals under development by biotech companies or pharmaceutical industry participants.
The question is, what strategies will contract biopharmaceutical producers adopt with respect to biogenerics? Will they eventually move into this market, risking alienating their present customer base, or will they instead stick to the innovator biopharmaceutical market? And will the industry be able to keep up with the demand?
Given the current capacity shortage for mammalian cell culture, it is quite likely that most contract biopharmaceutical companies will stick with present biopharmaceutical companies, making it difficult for biogeneric companies to gain access to bulk materials for their products.
Partnership among generic companies may help to solve the bulk material problem. There has been significant consolidation within the generic industry in the past few years, which should better position the industry to produce and compete within the biopharmaceutical market. Such competitive developments indicate a promising future for biosimilars. It may take a decade or more, but it is clear that there will be a strong generic biologic market in the U.S.