Efforts to Make Biologics More Affordable
Part of the Healthcare Reform Act targeted the creation of cheaper versions of biologic drugs (often called "follow-on biologics"). After a company has produced a biologic drug under patent for 12 years, other companies can produce similar versions of that drug, known as "biosimilar" drugs. But the process involved in producing a biosimilar drug is more complicated than it is to produce a traditional generic drug.
Biologic drugs are made from proteins taken from living cells. It's harder to prove that a biosimilar drug is as safe and effective as the original biologic. The FDA is still devising the requirements a drug will have to meet to be called "biosimilar."
Because companies may have to fund clinical studies to prove their drugs are biosimilar to the original, consumers may not save much with biosimilar drugs. It will be a while before we know how much money people might truly save with these drugs.