What Non-Pricing Factors Are Impacting Biosimilar Decision Making

In March of this year, FDA issued new draft guidance to reduce the cost and burden to produce biosimilars.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 While FDA’s draft guidance may alleviate some of the pressures when biosimilar developers, there are still other significant factors impacting the market.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: What non-pricing factors are impacting biosimilars decision making?
Thomas Newcomer: Right now, we'd like to see the evaluation of biosimilars become more holistic by all stakeholders. There's really been a drive over the last year where price is the absolute factor that most stakeholders are looking at for their choice of preference with a biosimilar.

What we'd like to bring to the table, or at least make it a discussion topic, is that this cannot be all about price. These products coming into the US that are intended to reduce the cost of care, all the biosimilars are going to deliver on that to varying degrees. The intricacy, however, is in the details of what else is included.

For example, you may have some products that have a skinny label versus a full package insert that matches the originator indications. You may have some biosimilars now, especially with a lot of the rule changes, that don't invest in phase three clinical trials, where others are investing in phase three clinical trials.

There's a clinical aspect that should be measured, one against another. It goes very deep when you get into patient support systems. There are some that just put videos on websites, some that just have pamphlets. There are other biosimilars that have full educational support. It could be a nurse visit to your house.

It varies between the biosimilars, and when you go further into copay or insurance support, that all varies as well. What we like to encourage is a holistic review of the entire product, not just the price point. These are not small molecule, generic drugs. These are specialty biologics and all of all of these factors need to be evaluated in in the decision making process.