A Long Time Coming: Dr Sophia Humphreys Details What’s Coming Down the Biosimilar Pipeline

As adalimumab biosimilars begin to enter the market, the United States continues to see growth in biosimilar uptake and is preparing for a wave of new products coming down the pipeline in the next few years, said Sophia Z. Humphreys, PharmD, MHA, BCBBS, the director of system pharmacy formulary management and clinical programs at Sutter Health, during at the Festival of Biologics.

Her presentation, called “The future of biosimilar market outlook and the financial impact to global/US,” took place on the last day of the March 20 to March 22, 2023 conference in San Diego, California.

Currently, most biosimilars are marketed between 30% and 50% lower than their reference products. Humphreys noted that biosimilars have also led originator manufacturers to drop the prices of their reference products by an average of 25%.

Humphreys stressed that although lowering prices is a positive thing, the industry should keep in mind whether those reductions impact patients, as many patients may not see their co-payments decrease. However, lower costs have contributed to higher utilization rates of biosimilars, which have amounted to 364 million patient days usage of the biosimilar molecules, 150 million more patient days than if biosimilar competition didn’t exist.

When looking at the growing adoption rates, after the first 36 months of biosimilar competition, oncology biosimilars had the highest market share (82%), followed by hematology, rheumatology, and gastroenterology. The clinical area with the lowest market share was ophthalmology (1%). However, Humphreys expressed that this was because these products were new on the market and that it will take time to see the true uptake rate.

Despite these numbers, Humphreys drew attention to the fact that of the 40 FDA-approved biosimilars for 14 molecules, only 67% of them have launched so far. In 2023, at least 10 are expected to enter the market, including a minimum of 8 adalimumab biosimilars, a few oncology biosimilars (pegfilgrastim, filgrastim, and bevacizumab), and possibly a couple ustekinumab products at the end of the year (pending FDA approval).

Regarding the adalimumab biosimilars, Humphreys noted the differences between the products, including that all are citrate-free except 1, only 1 has an interchangeability designation, and 2 have high-concentration options.

When Humphreys asked the audience whether they think citrate-free or interchangeability will be the biggest aspects to drive adalimumab biosimilar adoption, not many raised their hands. However, she pointed to survey data from Cardinal Health that found that rheumatologists felt that those factors will be very important when deciding which adalimumab product to use.

“Citrate-free will reduce injection site pain and would give patient a lot more comfort. So, that’s a preference for patients. And interchangeability is probably a preference of pharmacist. If you're a very busy pharmacist and you work with rheumatologists and you have to call them every time you want to switch a prescription or the [prior authorization] didn't get approved, you're spending a lot of time on the phone,” she explained.

What’s Coming Next?

Humphreys led with the promise of Actemra (tocilizumab) biosimilars because the originator started to be used in patients with COVID-19. Tocilizumab biosimilars are expected to launch with subcutaneous and intravenous administration methods. Additionally, subcutaneous and intravenous biosimilars for Soliris (eculizumab) are in development.

A biologics license application for a biobetter of Celltrion’s infliximab biosimilar (Remsima SC), which is the only infliximab product that will allow for subcutaneous administration, is under review with the FDA.

On the ophthalmology front, there are a few more ranibizumab biosimilars in development and upwards of 8 aflibercept biosimilars referencing Eylea in the pipeline.

In 2025, biosimilars for Xgeva and Prolia (denosumab) will enter the market for the treatment of osteoporosis. One biosimilar referencing Simponi (golimumab) is also in development.

Humphreys left with a few pieces of advice for the industry as it prepares to welcome biosimilars in existing and new drug classes.

“The confidence of payer and patients and physicians—my three P's—are very, very important. It's key for patient acceptance, for physician confidence, for payer uptake, and for biosimilar success…. Last but not least, always communicate, you can never over communicate because we still see confusion. If we see confusion about interchangeability within our audience, who are all experts here, then you can imagine if I go to a ophthalmologist to tell them that a particular Lucentis [ranibizumab] biosimilar is interchangeable. We're going to need to have a bigger conversation.”