Tom Newcomer’s Fireside Session at Reuters Events: Total Health

As of December 2025, the number of biosimilars in the United States has risen to 85 biosimilar approvals and 61 launches, reflecting the market’s accelerating pace and growing complexity. However, the lukewarm rate of biosimilar adoption in the past two to three years reveals how difficult it can be for biosimilars to gain meaningful traction in the US market. Tom Newcomer, Vice President and Head of US Commercial Operations, Samsung Bioepis, sat down with Dennis Dailey, Executive Producer of HIT.Show to discuss the current state of the US biosimilar market, roadblocks to adoption, and what it means for stakeholders at Reuters’ Total Health 2025, held in Chicago (October 28-29).

Biosimilars have been available for 10 years in the US and have saved the US healthcare system $56 billion to date.ⁱ “That is a tremendous amount of money. The problem is they're underutilized,” Tom pointed out.

Citing the Samsung Bioepis biosimilar market report, Tom explained that the oncology class and supportive care have seen fast acceptance of biosimilars, but some of the therapeutic areas that would be considered more chronic in nature or continuous therapy are the ones that are slower to see change. “We just see patients continue on the reference product month after month, which to the patient means they could be paying hundreds to thousands of dollars more every month.”

When asked about why there hasn’t been a broad adoption of biosimilars, Tom answered there are two main reasons, and the first one is lack of awareness. “(as a provider or a patient) If you're not having that conversation about biosimilars when there's a biosimilar available, then there's a gap from an awareness standpoint.” Tom compared the situation to generics; when patients go to the pharmacy, they are usually asked whether they want to be on the generic first, but biosimilars, unfortunately, are not at that level of awareness yet in the US market.

In addition to lack of awareness, a larger reason is misaligned incentives. “What I mean by misaligned incentives is there are many facets of the US healthcare system where the stakeholder, whoever they may be, are incentivized to use the higher dollar product,” and that does not play well for biosimilars. “Adoption is not where it needs to be for long-term success. We need to see adoption expedited, which has to happen at the ground level. We need to see biosimilars put into the marketplace.”

Lastly, Tom pointed out the biggest threat to the industry, void in future biosimilar pipeline. “In the next five to 10 years, you are going to see a large number of specialty biologics — probably around 118 — that are going off patent. Over 90% of those no longer have a biosimilar in development. The reason they don't have a biosimilar in development is because manufacturers cannot see the return on the investment currently.”

For developers to continue investing in biosimilars in high-cost drug categories in the future, Tom emphasized that there has to be a level of confidence that the market will support lower-cost biosimilars when they are approved years down the line. The US needs a more systematic approach, where biosimilars can be preferred over reference products. “Overall, it needs to be a biosimilar first strategy. And that starts really at the PBM (pharmacy benefit manager) level when their formularies are developed. It needs to be the health plan that hires the PBM to manage their formulary, demanding that they get the biosimilar first policy. It needs to be the employer groups that are paying for the health insurance who are saying, ‘why am I paying so much for reference products when I could be using these biosimilars that have now been out for up to 10 years.’ Those things need to happen,” Tom said. “We could be reducing the cost tomorrow for that class, which is then reducing the cost for everybody and enabling those dollars to go elsewhere.”

The full conversation of Tom’s fireside session titled “Biosimilar Market Trends, Latest Updates and their Implications” is available here: https://youtu.be/FMiNclBMwLU