Paving the way for a pivotal year for biosimilars

JJanuary 31 will mark the start of a pivotal year for the biosimilars industry with the release of Amjevita, the first biosimilar to Humira, the world’s top-selling medicine. Several other Humira biosimilars will also be marketed this year.

But without support from regulators and policymakers to make all biosimilars available on formularies, the full promise of these discounted drugs could be lost, costing the US healthcare system. $133 billion in the next three years.

It has been eight years since the FDA approved the first biosimilar in the United States. Nowadays, 40 biosimilars were approved in the United States after rigorous evaluation by the FDA; 25 of them are on the market.


Biosimilars have effectively encouraged price competition in the United States, directly saving patients money and forcing manufacturers of branded reference products to lower prices to retain market share. The move away from reference products begins almost immediately after a biosimilar is marketed and continues over time.

After all this progress, it pains me to say that the promise and growth of the biosimilars industry is under threat.


Launching a wave of Humira biosimilars throughout 2023 will help create a more competitive market that can significantly reduce prescription drug costs, but only if these and other biosimilars are available to people who need them. . Humira, which can cost upwards of $84,000 a year, has so far failed to face US competition with a 470% price increase since its launch in 2003. The cost of Amjevita and other biosimilars of Humira has not been announced, but is expected to be lower. what Humira costs.

Access to drugs is determined by formularies, the list of prescription drugs covered by a person’s health insurance plan. Treatments not included in a formulary – which is established by Pharmacy Benefit Managers (PBMs) – are not covered by insurance. Some formularies have excluded biosimilars, even though they represent equally effective but less expensive alternatives to branded reference products.

Americans shouldn’t face exorbitant prices on prescriptions and fewer options for the treatments they need due to the market dominance of brand name biologics and PBM shenanigans.

The Biden administration, Congress, and federal regulators must ensure that, as a starting point, the new Humira biosimilars will be available to all Americans covered by Medicare. A report 2021 by the Office of Inspector General of the Department of Health and Human Services found that Medicare could have saved more than $2 billion on Humira over four years if biosimilar competition had been available. It’s time to get all biosimilars listed on Medicare formularies to ensure seniors have access to lower-cost drug options.

Pharmacy benefit managers have declared their intention include only a limited number of Humira biosimilars on their formularies. This comes as the Federal Trade Commission investigation the business practices of the six largest PBMs in the United States. The FTC and other regulators should ensure that anticompetitive rebate programs and monopolistic tactics are removed from the formulary allocation process, and that lower-cost FDA-approved products are fully included in Medicare formularies.

Formularies tend to be for the full year, and newly launched drugs are not included until the following year. Pharmacy benefit managers and regulators should allow biosimilars and other new medicines to be added to formularies as they come online to ensure maximum competition, cost savings and access.

2023 is set to be a breakthrough year for drug pricing – if regulators, policymakers and pharmaceutical benefit managers deliver on the promise of biosimilars. A competitive and fair market that provides Americans with less expensive, safe, and effective treatment options is vital to the future of health care in the United States.

Juliana M. Reed is the Executive Director of the Biosimilars Forum.

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