Despite facing competition from nine lower-priced biosimilars in the past year, AbbVie’s (ABBV.N) blockbuster arthritis drug Humira has maintained over 80% of its patient base in the United States. This stronghold has led to questions about the sustainability of the biosimilar market in its current form, according to drug pricing experts and analysts.
Humira, which costs nearly $7,000 per month, is the first top-selling drug to encounter a wave of biosimilars—medications that are highly similar but not identical to branded biologic drugs. Despite their launch, pharmacy benefit managers (PBMs), who determine patient access, have shown little motivation to switch patients to these alternatives, experts say.
Limited Impact of Biosimilars
Although the three largest PBMs—CVS Health’s (CVS.N) Caremark, Cigna’s (CI.N) Express Scripts, and UnitedHealth Group’s (UNH.N) Optum Rx—offered biosimilars at lower prices, adoption has been minimal. It wasn’t until CVS removed Humira from its list of covered drugs that patients began to use biosimilars more widely.
“There’s no clear incentive for companies to invest time and money in creating biosimilars if they aren’t going to be used,” said Stacie Dusetzina, a health policy professor at Vanderbilt University. She emphasized the need for regulatory reforms to improve patient access and encourage the development of biosimilars. The biosimilar industry claims that $6 billion in potential savings have been lost since these alternatives were launched.
Regulatory and Market Dynamics
AbbVie declined to comment on the situation but previously stated that it had reduced Humira’s price to ensure it remained accessible alongside biosimilars on PBM lists. The company projects a 36% erosion in U.S. sales for Humira this year, with its peak annual sales exceeding $22 billion.
Unlike generic drugs, the FDA only permits certain biosimilars to be substituted for the branded medication by pharmacists, with most requiring specific prescriptions. Last year, bipartisan legislation was introduced to simplify the interchangeability of biosimilars. Both the government and lawmakers are scrutinizing PBM agreements with drugmakers, seeking reforms.
When six anticipated biosimilars for Johnson & Johnson’s (JNJ.N) $11 billion Crohn’s disease drug Stelara enter the U.S. market next year, experts predict a similar scenario to Humira’s. Joe Wolk, J&J’s Chief Financial Officer, expects the Stelara biosimilar market to follow Humira’s trajectory due to PBM contracting practices and resistance from doctors and patients.
PBM and Manufacturer Perspectives
Express Scripts and Optum representatives stated that they provide several options to help patients choose affordable medications, reducing costs for employers and insurers. CVS’s Chief Medical Officer, Sree Chaguturu, explained that the company continued covering Humira while assessing biosimilar manufacturers for quality and supply reliability. CVS now includes a Sandoz (SDZ.S) biosimilar and a co-branded Humira on its formulary through its new Cordavis pharmaceutical unit.
Challenges for Biosimilars
Benjamin Rome, a drug pricing researcher at Harvard Medical School, noted that because biosimilars are not exact copies, pharmacists require more information about their safety before switching patients. Zachary Wallace, a rheumatologist at Massachusetts General Hospital, mentioned that he and his colleagues started prescribing Sandoz’s Hyrimoz biosimilar when CVS stopped covering Humira. They were cautious about prescribing unfamiliar biosimilars without evidence of significant cost savings for patients.
In the U.S., drugmakers set a list price, which can be discounted for employers and insurers who receive volume-based rebates. Komal Gurnani, a consultant at ZS pharmaceuticals, predicted that up to five Humira biosimilars might exit the market within a few years before achieving her forecast of $400 million in peak sales. She expects companies like Amgen (AMGN.O), Sandoz, and South Korea’s Celltrion (068270.KS) to leverage their other products to negotiate favorable terms with insurers and remain competitive.
Commitment to the U.S. Market
Sandoz and Celltrion, which have long sold Humira biosimilars outside the U.S., stated their commitment to the American market. Celltrion’s Chief Commercial Officer, Tom Nusbickel, emphasized a long-term approach, willing to wait years for a significant market share. Indian drugmaker Biocon (BION.NS), which sells a Humira biosimilar in Europe, and Pfizer (PFE.N), which launched its biosimilar in October, also expressed their dedication to the U.S. market.
Boehringer, Teva (TEVA.TA), and Organon are committed to the U.S. despite market challenges. Organon’s biosimilar head, Jon Martin, is optimistic, even if biosimilars take six years to capture 50% market share, as seen with J&J’s Remicade.
The future of biosimilars in the U.S. hinges on regulatory changes and the ability of these alternatives to compete effectively in a market dominated by entrenched biologic drugs like Humira. The industry’s efforts and strategic adjustments will be crucial in ensuring biosimilars can provide affordable options for patients and reduce healthcare costs.
Meta Description: AbbVie’s Humira retains over 80% of its U.S. market share despite biosimilar competition, raising concerns about the viability of the biosimilar market and the need for regulatory reforms.
Related: AbbVie’s Stronghold on Humira Market Raises Concerns Over Biosimilars