In the developing world, there are over 2 dozen epoetin biosimilars on the market. However, while the choice is great for patients, the introduction of biosimilars do pose some challenges, and their introduction globally have provided some lessons.
With the inability to reproduce an identical molecule efficacy measurements and standardized analytical and pre-clinical tests for biosimilars are likely to be insufficient to demonstrate comparability of two biological products.
In summary, epoetin biosimilars have created competition in the marketplace and have brought down the cost of anemia treatment. However, their introduction (along with biosimilars of other types of drugs) has provided some lessons: biosmilars are not bio-identical, that they may differ from the innovator molecule in efficacy and potentially adverse effect, and that they require in place a robust pharamacovigilance infrastructure. The US will have epoetin biosimilars on the market within the next 3 to 5 years, that much is certain.