In my last post, I described some of the challenges generic makers are facing from a quality standpoint. To some extent, though, these are the same challenges manufacturers have always faced, just expanded as they develop generic versions of some of the largest selling drugs of all time. But these companies face real uncertainty in a completely new area: biologics.
The FDA is still developing its guidelines, but some of the proposals under consideration would force generic manufacturers to undertake clinical trials to demonstrate equivalency. Some might even force them to comply with marketing regulations.
This creates a number of new challenges for generics companies. They will need to develop the ability to conduct appropriate clinical trials. They may also need to develop their sales and marketing ability, since they will have to persuade doctors to prescribe their specific version of the biologic. By the time generics companies have built the required capabilities to comply with manufacturing, clinical trial, sales and marketing regulations, their cost structure is going to more closely resemble their pharma counterparts.