How Serious is the Biosimilar Void?

In March of this year, FDA issued new draft guidance to reduce the cost and burden to produce biosimilars. The guidance proposed the elimination of certain PK studies, including PK studies comparing the biosimilar to a US licensed reference product.

Pharmaceutical Executive spoke with Thomas Newcomer, SVP and head of US commercial at Samsung Bioepis about the biosimilar market in the United States. While FDA’s draft guidance may alleviate some of the pressures when biosimilar developers, there are still other significant factors impacting the market.

With the patent cliff looming, biosimilars can play an important role in the coming years. According to Newcomer, there are positive movements in areas like oncology. However, there is still a biosimilar void in the US that he says should be addressed.

Pharmaceutical Executive: How serious is the biosimilar void?
Thomas Newcomer: I would say there's definitely a biosimilar void that we're all aware of in the US market. Of course, there's several biosimilar manufacturers at this point in time. We expect a couple more to enter the US market, and that's naturally going to help address some of the issues of the high-priced biologic medicines not having a biosimilar option when they come off patent.

But, if you look at some of the most high-priced biologics, most people would agree there is a biosimilar in the works for those specific products. But it really is the ones in the middle that are causing the void.

It may be the ones that don't have a huge dollar volume attached to the originator units right now in the US market. It may be rare diseases that many biosimilar manufacturers have not entered into the space at this point in time from a developmental standpoint, but there absolutely is a void for what's coming off patent in just the next five years.