President Obama's first budget calls for the creation of a regulatory pathway for the creation of follow-on, or biosmiliar, biologics. This is obviously now the most high-profile call yet to move forward with a system that will provide the benefit of biotech drugs to patients who need them the most.
The biotech industry has done an outstanding effort in the last 10 years producing some of the most high-tech but also the most expensive drugs on the market. Some biotech medicines cost hundreds of thousands of dollars each year. Many of these products face no competition, because there is no legal way for a generic version of the product to get on the market. Individual patients as well as the healthcare system generally simply cannot absorb these continually rising costs.
To date, the debate over follow-on biologics has been mostly political posturing between the trade groups that represent the generic drug industry and the pioneering companies. The generic industry wants biotech companies to have only three to five years of market protection after bringing a new drug to market. The industry counters it needs up to 14 years of exclusivity to recapture its investment costs, which can reach over $1 billion for a single product.