An Overview of Biosimilars and Future Agents

Atheer Kaddis, PharmD, and Sonia T. Oskouei, PharmD, BCMAS, DPLA, provide an overview of biosimilars and the preparation for future launches on the horizon.

Sonia T. Oskouei, PharmD, BCMAS, DPLA: A biosimilar is an FDA-approved biologic treatment that is highly similar to an existing FDA-approved biologic that's on the market. So, a biosimilar is a biologic. A biologic is a category of treatments that are critical treatments and also the most costly treatments available that are made from living cells. It's important to note that biosimilars are biologics, and it's just the terminology used when the FDA approves highly similar versions of biologics that are already on the market.

Atheer Kaddis, PharmD: Biosimilars offer cost savings through lower list prices than the referenced brand name drugs. Typically, 15 to 25% lower list price is what we've experienced in the market since biosimilars were being approved by the FDA. And we also typically see rebates, being offered on biosimilars.

Sonia T. Oskouei, PharmD, BCMAS, DPLA: The key promise of biosimilars and the reason why there's so much passion and focus around this category of products is that they are intended to bring competition to some of the most costly treatment options available and the most critical treatments that we have to treat chronic and complex diseases. This is also done by bringing additional competition, thereby lowering costs and enhancing patient affordability and accessibility to these treatments.

Atheer Kaddis, PharmD: We're expecting several biosimilar competitors to the drug Humira. Humira is one of the most commonly used specialty medications in the United States. It's typically the highest spend drug for any health plan, in the United States. So, there is a lot of excitement building regarding biosimilar competition for Humira, which should help bring down overall pricing and spend, on Humira.

The biosimilars are supposed to become available in 2023. We are expecting several biosimilars to become available in 2023. Some of them become available later in the year, in 2023. One of the products is an interchangeable product to Humira. At this time, we are working with our pharmacy benefit manager, our PBM, to understand the negotiations that are taking place with the manufacturer for the brand name drug Humira, as well as the manufacturers of the biosimilars. This is to understand what the list price will be on the biosimilars, and what types of rebate contracts will be available for both Humira, the brand name reference drug, as well as the biosimilars that are coming to market.

We will meet with our pharmacy benefit manager to review the contracts that they've been able to negotiate on our behalf. So, we'll compare the reference brand net cost, to the biosimilar's net cost. We will then make a decision as to how we position the biosimilars, or whether we will continue to prefer the reference brand name drug over the biosimilars. I do want to mention there are some other considerations besides price, that we will review with our pharmacy benefit manager. That includes market share, on the reference brand, and how much market share we believe we can move to the biosimilars. We'll also review the FDA-approved indications for the biosimilars because some of these biosimilars may not have the same FDA-approved indications as Humira. They may have some of the same indications, but not all of the same indications. So, that will also limit our ability to move market share to the biosimilars.

Transcript edited for clarity.

Related Videos
James Howard, MD
Related Content
© 2023 MJH Life Sciences
All rights reserved.