Barriers to biosimilar prescription in RA treatment

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.^[] 

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.

AbbVie ‘halo’

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.^[]

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."  

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

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.  

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).^[]

PBMs

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.”

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.”