USA — The race to take on one of the most profitable drugs globally, AbbVie’s arthritis treatment Humira, has ignited fierce competition among manufacturers of generic biologics, known as biosimilars, in the United States.
With the potential to secure a share of the staggering US$19 billion in Humira’s U.S. sales from last year, these companies are employing diverse strategies to gain a coveted spot on insurers’ coverage lists.
The landscape of U.S. drug pricing is a labyrinthine puzzle, and biosimilars have faced their own set of challenges in making costly biologic medicines more affordable and accessible to patients.
Despite some exceptions, the promised rapid and widespread affordability has not materialized to its full potential.
Unlike generic pharmaceutical pills that often enter the market at significantly lower prices than their branded counterparts, biosimilars have not followed the same trajectory.
Several manufacturers have opted for a conservative approach, offering only a marginal public discount on their biosimilar Humiras and relying on private negotiations with insurer middlemen, known as pharmacy benefit managers, to secure coverage through rebates.
However, a few have taken a bolder approach by introducing steep upfront price cuts.
Boehringer Ingelheim, which launched its biosimilar at a 5% discount to Humira, claims it is “competitively priced.”
Called Cyltezo, Boehringer’s drug is the only biosimilar approved so far as an “interchangeable,” or able to be substituted directly by pharmacists without a specific prescription.
The diverse tactics being employed in this biosimilar showdown underscore the complexities of U.S. drug pricing and offer insights into why biosimilars have not yet delivered on their promise of affordability.
As the battle for Humira biosimilars intensifies, the outcome could provide valuable lessons as more biologic copycats enter the market in the years to come.
The dynamics of pricing for Humira biosimilars are closely monitored, given that no biologic drug has ever faced such intense competition in such a short period.
The competitive balance may determine whether AbbVie’s expected sales decline results from matching lower prices or losing volume that cannot be replaced.
According to recent surveys conducted by analysts, Humira has retained its market share in its primary indication, rheumatoid arthritis.
While declining use of the drug has been observed in digestive and skin conditions, AbbVie’s introduction of Skyrizi as a Humira successor has effectively offset this. Consequently, the brand’s stickiness in the market has surprised investors.
Biosimilar launches often follow similar trajectories, facing initial struggles before gradually gaining momentum.
Inflectra, a biosimilar alternative to Johnson & Johnson’s Remicade, faced challenges upon its initial launch but eventually made significant strides over time.
Competition has impacted Remicade’s average sales price and biosimilars now command nearly half of the market.
Other factors, such as the nature of the disease and value-based payment models, have also influenced the success of biosimilars.
Cancer treatment biosimilars have achieved higher market penetration compared to those for immune-related disorders like Humira and Remicade.
As major pharmacy benefit managers update their coverage lists in response to Humira biosimilars entering the market, the choices they make significantly impact consumers’ out-of-pocket costs.
The financial model of PBMs may evolve over time, leading to potential changes in cost-sharing and greater transparency in the passing on of rebates.
Two of the three largest PBMs in the U.S., Cigna Healthcare’s Express Scripts and United Healthcare’s Optum, have already updated their coverage lists in the wake of Humira biosimilars launching.
Both Express Scripts and Optum chose Cyltezo and Novartis’ Hyrimoz, along with an unbranded Novartis product, to add to their earlier selection of Amgen’s biosimilar.
The battle for Humira biosimilars in the U.S. continues to evolve, holding the promise of increased affordability and access for patients.
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