How Are Regulatory Factors Impacting Biosimilars

In March of this year, FDA issued new draft guidance to reduce the cost and burden to produce biosimilars.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 While FDA’s draft guidance may alleviate some of the pressures when biosimilar developers, there are still other significant factors impacting the market.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 are regulatory factors impacting biosimilars?
Thomas Newcomer: Those are all aspects that are impacting the biosimilar market. Depending on which one you're looking at, it could be in a subtle or it could be in a dramatic fashion.

One example would be if you are biosimilar manufacturer, and you began to develop a product years ago, and you've invested between $100-300 million, depending on the product and the product and the facilities that you're developing in. You're planning on entering the US market to bring that biosimilar into a specific therapeutic class, and now all of a sudden, that class isn't what you thought it was because of MFN or IRA implications that changes dramatically the planning and the execution for the company that is investing in these products years and years in advance.

For biosimilar manufacturers, we want to have some type of consistency on what the expectation is going to be when we're developing these products that eventually are intended to reduce the healthcare costs for all stakeholders down to the patient level. Some of these policies have unintended consequences and are changing the dynamics.

That's just from the pricing perspective. If you go further into some of the policies, like with tariffs, there's a lot of unknowns. There's really no set answer right now on how there will be impact to biosimilar manufacturers. There's speculation that maybe biosimilars will be exempt from tariffs, but then it depends on the country that the tariffs are going to be imposed upon.

If you look at biosimilar manufacturers, they're not all in the US. It's a rarity to be in the US. As far as the development and manufacturing process, most of these are overseas companies that are putting the dollars in to invest these products. Now, if you are a stakeholder, you should absolutely be evaluating where that product's coming from, because if it's coming from a country that has been targeted for tariffs, as we see in the news, you must wonder what the future is going to bring there.