Addressing Regulatory Issues and the Biosimilar Void: Q&A with Thomas Newcomer

In March of this year, FDA issued new draft guidance to reduce the cost and burden to produce biosimilars.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 While FDA’s draft guidance may alleviate some of the pressures when biosimilar developers, there are still other significant factors impacting the market.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.

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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.

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.

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.

Pharmaceutical Executive: How are biosimilars being adopted in oncology compared to immunology?
Thomas Newcomer: It has changed over the years. One thing everybody would align on is that the biosimilar market in oncology has done very well with uptake and adoption. There was rapid uptake in the oncology space.

The majority of patients and oncologists are embracing and using biosimilars, which is great. The more we see biosimilar use utilization, we can take the funding and put it into future products. The stakeholders you know, whether it is the employer, the health plan, or the PBM, can take those funds and put them into other areas of the business, all to improve the future.

Oncology has been a great example of that. I would say immunology has been a little bit slower, especially on the benefit side, but it has shown progress over the years. About half the utilization for the medical benefit immunology space would be in biosimilars favor, so it's still split between the originator and the biosimilars.

There has been progress in the last year or two, so it is getting better. It’s still slower than oncology, but it's still getting better. What we're interested to see is the newer therapeutic areas for biosimilars. You have entrance now into neurology, endocrinology, rare diseases, and ophthalmology. Those are new and exciting areas where biosimilars have now entered into the market, and we're now all waiting to see what the update is going to be for those respective categories.