Biosimilar uptake remains far lower in the US than in Europe.
In the US, legal challenges, coverage, and provider concerns hinder switching to biosimilars.
Increased coverage, policy changes, and educational efforts are some of the ways to boost biosimilar prescriptions.
Despite the Biologics Price Competition and Innovation Act of 2009, uptake of biosimilars has been sluggish. This slow adoption in the US stands in stark contrast to the EU, where a legal framework for approving biosimilars was established by the European Medicines Agency in 2003, with biosimilars first approved in 2006.
To date, there are 69 approved biosimilars in the EU, with the vast majority marketed immediately following approval. In contrast, the US FDA has approved only 43 biosimilars, of which 18 have been launched.
Biosimilars to treat RA have been a hot topic in recent months, with nine currently approved. But even with more TNF inhibitors on the market in the form of biosimilars, getting specialists and policy makers on board is still a challenge.
At least nine Humira (adalimumab) biosimilars had an anticipated launch in 2023, with one coming out in January 2023 (Amjevita) and eight coming out in July. The eight launched in July, as listed in an article in The Rheumatologist, were adalimumab-adbm (Cytezlo); adalimumab-adaz (Hyrimoz); adalimumab-aqvh (Yusimry); adalimumab-bwwd (Hadlima) and adalimumab-atty (Yuflyma); adalimumab-fkjp (Hulio); adalimumab-afzb (Abrilada); and adalimumab-aacf (Idacio). Cytezlo is the only biosimilar that’s approved as interchangeable with Humira.Related: Breakthroughs in rheumatology: These drugs show the most promise in RA treatment
According to the results of a recent survey by Spherix Global Insights exploring specialists’ sentiments on biosimilars—involving 85 rheumatologists, among other specialists—specialists are not averse to biosimilars, although they are reluctant to switch patients from the reference product Humira to a biosimilar.
As one rheumatologist commented, "If Humira is working, don't mess with success by switching to a biosimilar."
AbbVie’s appeal to rheumatologists, gastroenterologists, and dermatologists arose from its large portfolio of effective agents (eg, Humira, Skyrizi, Rinvoq), as well as robust patient and practice support programs. These factors create an uphill battle for any other biosimilar manufacturer.
Another deterrent to prescribing biosimilars, expressed by the survey respondents, is that it is unclear whether these drugs will produce substantial savings. Amjevita, for example, has yet to provide an influential cost-saving strategy. In fact, immunologists believe that the greatest savings will be provided to the overall health system and insurers—not the patients and practices.
On the other hand, Coherus did announce that their adalimumab biosimilar Yusimry, which launched in July 2023, will cost 85% less than AbbVie's originator Humira wholesale acquisition cost (WAC). In the end, increased accessibility at lower cost may be the key to increasing the uptake of Humira biosimilars.
Legal wrangling played a major role in delayed rollouts of rheumatology biosimilars. The FDA approved Amgen’s Amjevita in 2016, and many practitioners thought that commercial availability was imminent. However, legal battles with AbbVie for years over Humira patent violations delayed the launch. A settlement allowed Amjevita to enter the market in 2023.Related: Falling behind: The US has been slow to integrate new biosimilars for treating RA
In other legal proceedings, described in the AMA Journal of Ethics, Sandoz reached a global settlement with AbbVie with regard to claims that the biosimilar adalimumab infringed on patents shielding the reference biologics. Predictably, AbbVie has a history of fiercely safeguarding its claim to Humira, which raked in $18.4 billion in 2017. To put that number in perspective, that’s more than double the take of its next closest competitor, Revlimid (lenalidomide).
It remains to be seen how payers will reimburse and make available new biosimilar products relative to reference biologics, say the authors of the article in The Rheumatologist. To date, little insight on this topic has been provided, which makes for a steep learning curve for providers.
In early 2023, many formularies were carrying Amjevita and Humira, although it's unlikely that any formulary will carry all Humira biosimilars. It’s also unclear whether biosimilars will be covered at parity with the reference product. Another possibility is that AbbVie may decide to finagle better deals with PBMs to keep market share.
In the article, Simon M. Helfgott, MD, associate professor of medicine in the Division of Rheumatology and Immunology at Harvard Medical School, questioned the motives and goals of PBMs.
“I think a lot of people’s concerns are that the objectives and goals of the PBMs are not always aligned with the objectives and goals of the patient or the prescriber. We’re going to have new products on the market, and what the prescriber may think is the appropriate thing to do may not be what the PBM has in mind at all,” Dr. Helfgott said. “Insurance for patients changes frequently, and the formulary changes frequently. If I knew what would be covered for the next five years, I would choose that adalimumab version because I would ideally not have it changed multiple times. But at the same time, it’s reassuring that these drugs have been proved to be equal in how they work.”
What can be done
For its part, CMS is offering a temporary payment increase for qualifying biosimilars under Medicare Part B. Part B typically pays the Average Sales Price (ASP) plus 6% of the reference biological product’s ASP when the biosimilar is separately payable in specialist offices, hospital outpatient departments, and ambulatory surgical centers.
Per CMS, “The goal of the temporary add-on payment for providers is to increase access to biosimilars, as well as to encourage competition between biosimilars and reference biological products, which may, over time, lower drug costs and lead to savings to beneficiaries and Medicare.”
Various solutions have been presented to increase the use of biosimilars, according to the authors of the article in the AMA Journal of Ethics.
The authors wrote that “legislation could be passed to increase the transparency in reporting of biologic patents, which would allow biosimilar manufacturers to more readily challenge their validity. Additionally, regulatory agencies could scrutinize the anticompetitive practices of exclusionary contracts and enact stronger regulations against such practices. Lastly, the FDA could increase its efforts to educate physicians and the public about the bioequivalence of biosimilars and remove unnecessary naming policies that cause confusion among users, including the 4-letter suffixes given exclusively to biosimilars for the sole purpose of distinguishing them from their originators. Addressing these issues will inevitably result in increased biosimilar use.”
What this means for you
Although biosimilars are viewed by most physicians as safe and effective, various barriers limit their use. Looking forward, the uptake of RA and other biosimilars will depend on what payers choose to cover and to what extent. Various solutions have been proposed to increase the uptake of biosimilars but much clarification and work needs to be done before they become a routine—and interchangeable—option.