Webinar Addresses Solutions to Improve Adalimumab Biosimilar Uptake

Government policies, including those related to prescribing incentives and interchangeability, need to be reworked to encourage biosimilar adoption and create meaningful savings for health systems, according to speakers at a recent webinar.

The webinar dubbed “March of the Biosimilars,” which was sponsored by Samsung Bioepis and hosted by STAT News, addressed the US launches of 9 adalimumab biosimilars in 2023, which marked the highest number of biosimilars for a single reference product (Humira) to launch within one year. Although uptake has been low so far—only 2% according to Samsung Bioepis’ Biosimilar Market Report—, the speakers championed efforts to improve competition and market sustainability.

“In the United States, we often hear about concerns over the high cost of medicines. But biosimilars have yet to become an integral part of the public discussion on health care costs. It is imperative to all stakeholders within the US health care system, from manufacturers to patients that we see an uptake and market penetration for biosimilars in 2024 and beyond,” said Thomas Newcomer, vice president and head of US market access at Samsung Bioepis. “We need to ensure that a thriving biosimilar market is the centerpiece of any legislative discussion.”

A major reason for the low uptake of adalimumab biosimilars was that AbbVie, the maker of Humira, tied its rebate negotiations with pharmacy benefit managers (PBMs) to Rinvoq (upadacitinib) and Skyrizi (rizankizumab-rzaa) to ensure that Humira would be kept on the list at parity with any biosimilars the PBM decides to add to formulary, according to Chris M. Brown, president of McAteer. Brown noted that this practice had disincentivized PBMs and health systems from prioritizing biosimilars.

“None of the major payers at all, with the exception of Kaiser [Permanente] removed Humira [from formulary]. And if you look at AbbVie’s quarterly results, you can see the price [of Humira] went down, but 96% of their unit volume is still there. So, there's no traction [for biosimilars] whatsoever. If [a health system] can get the same benefit price-wise from a biosimilar, they don't really have to do anything else,” commented Michael Gonzales, independent health care consultant and AbbVie’s former national and regional account director.

Gonzalez also discussed the unwillingness of gastroenterologists to switch patients from the reference product to a biosimilar, largely because these patients have chronic conditions and have likely had to try multiple medications before feeling comfortable with Humira.

The speakers mentioned potential policy solutions to boost uptake, including:

• Eliminating the interchangeability designation in the biosimilar approval process to simplify it.
• Allowing all approved biosimilars to be considered interchangeable, as proposed in the Biden administration's budget, to reduce confusion.
• Passing legislation like the Red Tape Elimination Act to remove switching study requirements to obtain interchangeability designations.
• Having payers take a longer-term view like manufacturers and match their strategies, such as negotiating rebates, to create a more robust biosimilars industry.
• Potentially removing rebates from the system altogether to reduce perverse incentives against lower-cost products.
• Having government intervention to establish a more level playing field among biosimilar competitors through policies like those mentioned above.

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, highlighted that value-based care models may be part of the reason why biosimilar uptake has been so much higher in oncology vs rheumatology. She also warned that lack of uptake will disincentivize companies from wanting to participate in the biosimilar space in the future.

“We’ve generated cost savings in the short term. But what's interesting to a manufacturer of a biosimilar if you get no market share? That becomes very uninteresting. Over time, maybe there's no interest at all, and we don't have any cost savings as a result. So, we have to think about the long-term when we think about the benefit of biosimilars. It's not a short-term benefit; it's a long-term benefit that the industry of biosimilars is expected to deliver to health care.”