AbbVie’s (ABBV.N) top-selling arthritis drug Humira has managed to retain over 80% of its patient base in the U.S. despite the introduction of nine lower-priced biosimilar competitors over the past year. This development raises significant concerns about the viability of the biosimilar market, according to drug pricing experts and analysts.
Humira’s Dominance
Humira, which is priced at nearly $7,000 per month, is the first leading drug to face competition from multiple biosimilars—biologic medicines that are similar, but not identical, to branded drugs. Despite the availability of these biosimilars at lower prices, pharmacy benefit managers (PBMs) have played a crucial role in limiting patient access by not incentivizing doctors to switch to these alternatives.
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 reduced prices. However, uptake remained low until CVS removed AbbVie’s Humira from its list of covered drugs.
Need for Regulatory Reform
Stacie Dusetzina, a health policy professor at Vanderbilt University, emphasized the necessity for regulatory reforms to facilitate easier access to biosimilars and encourage rival drugmakers to develop them. “There’s no clear incentive for companies to invest in biosimilars if they aren’t used, meaning the price of the brand would never decrease,” she said. The biosimilar industry advocates for regulatory changes, citing a loss of $6 billion in potential savings since their introduction.
AbbVie, while declining to comment, has previously stated that it conceded on price to secure equal access for Humira alongside biosimilars on PBM lists. The company expects a 36% erosion in U.S. sales for Humira this year, which peaked at annual sales of $22 billion.
Biosimilar Challenges
Unlike generic drugs, the FDA only allows certain biosimilars to be substituted for the branded medicine by pharmacists, with most requiring specific prescriptions. Last year, bipartisan legislation was introduced to make biosimilar interchangeability easier. Government officials and lawmakers are also scrutinizing PBM deals with drugmakers.
Experts predict that when six biosimilars for Johnson & Johnson’s (JNJ.N) $11 billion Crohn’s disease drug Stelara hit the U.S. market next year, private insurers will likely follow the same playbook used for Humira. J&J’s Chief Financial Officer Joe Wolk noted that the Stelara biosimilar market might mirror Humira’s due to PBM contracting practices and resistance from doctors and patients.
PBM and Manufacturer Responses
Representatives from Express Scripts and Optum stated that they provide multiple options to help patients choose affordable medicines, thereby reducing costs for employers and insurers. CVS Chief Medical Officer Sree Chaguturu explained that the company continued to cover Humira while evaluating biosimilar manufacturers for quality and supply reliability. CVS now covers a Sandoz (SDZ.S) biosimilar and a co-branded Humira through its new Cordavis pharmaceutical unit.
Market Viability
Benjamin Rome, a drug pricing researcher at Harvard Medical School, highlighted that biosimilars are not exact copies like generics, necessitating more information about their safety before pharmacists switch patients. Rheumatologist Zachary Wallace of Massachusetts General Hospital began prescribing Sandoz’s Hyrimoz biosimilar after CVS stopped covering Humira but remains cautious about prescribing unfamiliar biosimilars without proof of significant patient savings.
Drugmakers set list prices for their drugs, which can be discounted for employers and insurers through 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 reaching peak sales of $400 million. She expects companies with other biosimilar launches, like Amgen (AMGN.O), Sandoz, and South Korea’s Celltrion (068270.KS), to leverage their broader product portfolios to negotiate favorable terms with insurers.
Commitment to the U.S. Market
Sandoz and Celltrion, which have long sold Humira biosimilars outside the U.S., reiterated their commitment to the American market. Celltrion’s Chief Commercial Officer Tom Nusbickel stated that the company is willing to wait years to gain a significant U.S. foothold. Indian drugmaker Biocon (BION.NS) and Pfizer (PFE.N), which launched its biosimilar in October, also expressed dedication to the U.S. market.
Boehringer, Teva (TEVA.TA), and Organon remain committed to the U.S. despite market challenges. Organon’s biosimilar head Jon Martin expressed optimism, even if biosimilars take six years to gain 50% market share, as seen with J&J’s arthritis drug Remicade.
The future of biosimilars in the U.S. hinges on regulatory changes and the ability of these alternatives to compete effectively against entrenched biologic drugs like Humira. The industry’s efforts and strategic adjustments will be crucial in ensuring biosimilars provide affordable options for patients and reduce healthcare costs.
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Source: Reuters